PAC2 - Medical Devices and Incidents
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PAC2 - Medical Devices and Incidents

Release: 2026-04-04

This version:
http://www.noel-garcia.org/ontologies/medical-devices/1.0.0
Latest version:
http://www.noel-garcia.org/ontologies/medical-devices
Revision:
1.0.0
Issued on:
2026-04-27
Authors:
Noël García Pou
Download serialization:
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License:
https://creativecommons.org/licenses/by/4.0/ License
Visualization:
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Cite as:
Noël García Pou. PAC2 - Medical Devices and Incidents. Revision: 1.0.0. Retrieved from: http://www.noel-garcia.org/ontologies/medical-devices/1.0.0
Ontology Specification Draft

Abstract

This ontology was created for a university project to model how medical device incidents and risks are managed in Europe. The main goal is to have a clear way to link devices with the problems they might cause and the safety actions taken to fix them.

Introduction back to ToC

In the medical world, keeping track of device safety is complicated, especially with the European rules (MDR and IVDR). If a pacemaker or a scanner fails, there needs to be a clear record of what happened and what was done about it.

PAC2 - Medical Devices and Incidents: Overview back to ToC

This ontology has the following classes and properties.

Classes

Object Properties

Data Properties

Named Individuals

SWRL Rules

PAC2 - Medical Devices and Incidents: Description back to ToC

European high-risk medical devices.

Cross-reference for PAC2 - Medical Devices and Incidents classes, object properties and data properties back to ToC

This section provides details for each class and property defined by PAC2 - Medical Devices and Incidents.

Classes

Action Typec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ActionType

The type of corrective action taken in response to an incident.
has sub-classes
In Situ Correction c, Recall c, Safety Alert c, User Notice c
is in domain of
is action type of op
is in range of
has action type op

Active Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ActiveDevice

A medical device that relies on a source of energy other than the human body.
has super-classes
Device Type c
has sub-classes
Implantable Active Device c
has members
Active_Device_Type ni
is disjoint with
Active Implant c, In Vitro Diagnostic Device c, Self Test Device c, Single Use Device c

Active Implantc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ActiveImplant

A surgically inserted medical device that relies on an external power source to function.
has super-classes
Device Type c
has members
Active_Implant_Type ni
is disjoint with
Active Device c, In Vitro Diagnostic Device c, Self Test Device c, Single Use Device c, Implantable Device c, In Vitro Diagnostic Device c, Self Test Device c, Single Use Device c

Class Ac back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassA

Risk Class A for in vitro diagnostic devices according to the IVDR framework.
has super-classes
Device Risk Class c
has members
Class_A ni
is disjoint with
Class B c, Class C c, Class D c, Class I c, Class I I I c, Class I Ia c, Class I Ib c

Class Bc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassB

Risk Class B for in vitro diagnostic devices according to the IVDR framework.
has super-classes
Device Risk Class c
has members
Class_B ni
is disjoint with
Class A c, Class C c, Class D c, Class I c, Class I I I c, Class I Ia c, Class I Ib c

Class Cc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassC

Risk Class C for in vitro diagnostic devices according to the IVDR framework.
has super-classes
Device Risk Class c
has members
Class_C ni
is disjoint with
Class A c, Class B c, Class D c, Class I c, Class I I I c, Class I Ia c, Class I Ib c

Class Dc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassD

Risk Class D for in vitro diagnostic devices according to the IVDR framework.
has super-classes
Device Risk Class c
has members
Class_D ni
is disjoint with
Class A c, Class B c, Class C c, Class I c, Class I I I c, Class I Ia c, Class I Ib c

Class Ic back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassI

Risk Class I for medical devices according to the MDR framework.
has super-classes
Device Risk Class c
has members
Class_I ni
is disjoint with
Class A c, Class B c, Class C c, Class D c, Class I I I c, Class I Ia c, Class I Ib c

Class I I Ic back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassIII

Risk Class III for medical devices according to the MDR framework.
has super-classes
Device Risk Class c
has members
Class_III ni
is disjoint with
Class A c, Class B c, Class C c, Class D c, Class I c, Class I Ia c, Class I Ib c

Class I Iac back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassIIa

Risk Class IIa for medical devices according to the MDR framework.
has super-classes
Device Risk Class c
has members
Class_IIa ni
is disjoint with
Class A c, Class B c, Class C c, Class D c, Class I c, Class I I I c, Class I Ib c

Class I Ibc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ClassIIb

Risk Class IIb for medical devices according to the MDR framework.
has super-classes
Device Risk Class c
has members
Class_IIb ni
is disjoint with
Class A c, Class B c, Class C c, Class D c, Class I c, Class I I I c, Class I Ia c

Contamination Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ContaminationRisk

A risk associated with contamination of a device by biological, chemical, or other substances.
has super-classes
Risk Type c
has members
Contamination_Risk_Type ni
is disjoint with
Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Corrective Actionc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#CorrectiveAction

An action taken to manage a safety issue related to a medical device.
has super-classes
is in domain of
action date dp, closure date dp, countries affected dp, description dp, devices affected dp, eudamed f s c a ref dp, has action type op, related to incident op, scope dp, status dp
is in range of
has corrective action op, is action type of op
has members
FSCA-001 (Safety Alert) ni, FSCA-002 (Recall) ni, FSCA-003 (In Situ Correction) ni, FSCA-004 (Safety Alert) ni, FSCA-005 (In Situ Correction) ni, FSCA-006 (Recall) ni, FSCA-007 (User Notice) ni, FSCA-008 (Recall) ni, FSCA-009 (User Notice) ni, FSCA-010 (Recall) ni, FSCA-011 (In Situ Correction) ni, FSCA-012 (Recall) ni, FSCA-013 (Safety Alert) ni, FSCA-014 (User Notice) ni, FSCA-015 (In Situ Correction) ni
is disjoint with
Device c, Incident c, Manufacturer c, Risk c

Criticalc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Critical

A severity level indicating life-threatening or fatal consequences.
has super-classes
Severity Level c
has members
Critical_Sev ni
is disjoint with
Moderate c, Serious c

Cybersecurity Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#CybersecurityRisk

A risk related to unauthorized access, data breaches, or cyber attacks affecting a medical device.
has super-classes
Risk Type c
has members
Cybersecurity_Risk_Type ni
is disjoint with
Contamination Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Device Failurec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DeviceFailure

A risk category related to malfunction or failure of a medical device.
has super-classes
Risk Category c
has members
Device_Failure_Cat ni
is disjoint with
Device Performance c, Device Safety c, Diagnostic Error c, Patient Harm c, Product Quality c

Device Performancec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DevicePerformance

A risk category related to issues affecting the performance of a medical device.
has super-classes
Risk Category c
has members
Device_Performance_Cat ni
is disjoint with
Device Failure c, Device Safety c, Diagnostic Error c, Patient Harm c, Product Quality c

Device Risk Classc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DeviceRiskClass

A classification level indicating the risk associated with a medical device.
has sub-classes
Class A c, Class B c, Class C c, Class D c, Class I c, Class I I I c, Class I Ia c, Class I Ib c
is in domain of
is risk class of op
is in range of
has risk class op

Device Safetyc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DeviceSafety

A risk category concerning the safety aspects of a medical device.
has super-classes
Risk Category c
has members
Device_Safety_Cat ni
is disjoint with
Device Failure c, Device Performance c, Diagnostic Error c, Patient Harm c, Product Quality c

Device Typec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DeviceType

The type of the device
has sub-classes
Active Device c, Active Implant c, Implantable Device c, In Vitro Diagnostic Device c, Self Test Device c, Single Use Device c
is in domain of
is device type of op
is in range of
has device type op

Diagnostic Errorc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DiagnosticError

A risk category involving incorrect diagnostic results produced by a device.
has super-classes
Risk Category c
has members
Diagnostic_Error_Cat ni
is disjoint with
Device Failure c, Device Performance c, Device Safety c, Patient Harm c, Product Quality c

Diagnostic Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DiagnosticRisk

A risk involving incorrect or unreliable diagnostic results produced by a device.
has super-classes
Risk Type c
has members
Diagnostic_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Highc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#High

A probability level indicating a high likelihood of occurrence.
has super-classes
Probability Level c
has members
High_Probability_Type ni
is disjoint with
Low c, Medium c

Implantable Active Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ImplantableActiveDevice

An active device intended to be completely or partially introduced into the body.
has super-classes
Active Device c, Implantable Device c
has members
Implantable_Active_Type ni

Implantable Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ImplantableDevice

A device intended to be placed inside the human body.
has super-classes
Device Type c
has sub-classes
Implantable Active Device c
has members
Implantable_Type ni
is disjoint with
Active Implant c, In Vitro Diagnostic Device c, Self Test Device c, Single Use Device c

In Situ Correctionc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#InSituCorrection

A corrective action performed directly on the device at its location without removing it.
has super-classes
Action Type c
has members
In_Situ_Correction_Type ni
is disjoint with
Recall c, Safety Alert c, User Notice c

In Vitro Diagnostic Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#InVitroDiagnosticDevice

A device used to perform tests on samples outside the human body
has super-classes
Device Type c
has members
In_Vitro_Diagnostic_Device_Type ni
is disjoint with
Active Device c, Active Implant c, Self Test Device c, Single Use Device c, Active Implant c, Implantable Device c, Self Test Device c, Single Use Device c

Incidentc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Incident

An event related to a medical device that may cause or has caused harm.
has super-classes
is in domain of
corrective action taken dp, country reported dp, description dp, detection date dp, eudamed incident ref dp, event date dp, has corrective action op, has incident type op, has risk op, involves device op, outcome dp, patient age dp, patient sex dp, report date dp, reported by op
is in range of
has incident recorded op, has reported op, is incident type of op, is manifested in op, related to incident op
has members
Incident INC-001 (Embolic stroke) ni, Incident INC-002 (Battery depletion) ni, Incident INC-003 (Valve migration) ni, Incident INC-004 (Stent fracture) ni, Incident INC-005 (Lead dislodgement) ni, Incident INC-006 (System failure) ni, Incident INC-007 (Tissue reaction) ni, Incident INC-008 (Cobalt toxicity) ni, Incident INC-009 (Inappropriate shock) ni, Incident INC-009 (Inappropriate shock) ni, Incident INC-011 (False positive TSH) ni, Incident INC-012 (False negative SARS-CoV-2) ni, Incident INC-013 (False negative HIV) ni, Incident INC-014 (Hyperglycaemic event) ni, Incident INC-015 (Drug overdose) ni, Incident INC-016 (Haemolytic anaemia) ni, Incident INC-017 (Endophthalmitis) ni, Incident INC-018 (Cybersecurity vulnerability) ni, Incident INC-019 (Activation failure) ni, Incident INC-020 (SAR heating injury) ni
is disjoint with
Corrective Action c, Device c, Manufacturer c, Risk c

Incident Typec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#IncidentType

The classification of the reported incident.
has sub-classes
Near Miss Incident c, Serious Incident c
is in domain of
is incident type of op
is in range of
has incident type op

Infection Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#InfectionRisk

A risk related to the potential transmission of infections through the use of a medical device.
has super-classes
Risk Type c
has members
Infection_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Injury Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#InjuryRisk

A risk involving physical harm or injury to a patient or user caused by a device.
has super-classes
Risk Type c
has members
Injury_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Interference Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#InterferenceRisk

A risk caused by flaws in the interaction (physical, cognitive, or logical) between the person and the device.
has super-classes
Risk Type c
has members
Interference_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c

Lowc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Low

A probability level indicating a low likelihood of occurrence.
has super-classes
Probability Level c
has members
Low_Probability_Type ni
is disjoint with
High c, Medium c

Malfunction Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MalfunctionRisk

A risk related to the failure or malfunction of a medical device.
has super-classes
Risk Type c
has members
Malfunction_Rick_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Material Risk c, Radiation Risk c, Software Risk c

Manufacturerc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Manufacturer

An organization responsible for producing medical devices and registering them in EUDAMED.
has super-classes
is in domain of
authorization number dp, competent authority dp, country dp, email dp, eudamed s r n dp, has reported op, is manufacturer of op, name dp
is in range of
has manufacturer op, reported by op
has members
Abbott Medical Devices ni, Biotronik SE & Co. KG ni, Boston Scientific Corporation ni, Drägerwerk AG & Co. KGaA ni, GE HealthCare Technologies ni, Hologic Inc. ni, LivaNova PLC ni, Medtronic plc ni, Nipro Corporation ni, Philips Medical Systems ni, Roche Diagnostics GmbH ni, Siemens Healthineers AG ni, Stryker Corporation ni, Zimmer Biomet Holdings ni, bioMérieux SA ni
is disjoint with
Corrective Action c, Device c, Incident c, Risk c

Material Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MaterialRisk

A risk associated with the materials used in a device.
has super-classes
Risk Type c
has members
Material_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Radiation Risk c, Software Risk c

Mediumc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Medium

A probability level indicating a moderate likelihood of occurrence.
has super-classes
Probability Level c
has members
Medium_Probability_Type ni
is disjoint with
High c, Low c

Moderatec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Moderate

A severity level indicating moderate health impact requiring intervention.
has super-classes
Severity Level c
has members
Moderate_Sev ni
is disjoint with
Critical c, Serious c

Near Miss Incidentc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#NearMissIncident

A Near Miss incident involving a medical device.
has super-classes
Incident Type c
has members
Near_Miss_Incident_Type ni
is disjoint with
Serious Incident c

Patient Harmc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#PatientHarm

A risk category involving injury or harm caused to a patient.
has super-classes
Risk Category c
has members
Patient_Harm_Cat ni
is disjoint with
Device Failure c, Device Performance c, Device Safety c, Diagnostic Error c, Product Quality c

Probability Levelc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ProbabilityLevel

The likelihood of a risk occurring.
has sub-classes
High c, Low c, Medium c
is in domain of
is probability of op
is in range of
has probability op

Product Qualityc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#ProductQuality

A risk category related to defects or quality issues in a medical device.
has super-classes
Risk Category c
has members
Product_Quality_Type ni
is disjoint with
Device Failure c, Device Performance c, Device Safety c, Diagnostic Error c, Patient Harm c

Radiation Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RadiationRisk

A risk related to exposure to harmful radiation emitted by a device.
has super-classes
Risk Type c
has members
Radiaton_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Software Risk c

Recallc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Recall

A corrective action involving the removal of a medical device from the market or its return due to safety concerns.
has super-classes
Action Type c
has members
Recall_Type ni
is disjoint with
In Situ Correction c, Safety Alert c, User Notice c

Risk Categoryc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RiskCategory

A category grouping different types of risks.
has sub-classes
Device Failure c, Device Performance c, Device Safety c, Diagnostic Error c, Patient Harm c, Product Quality c
is in domain of
is risk category of op
is in range of
has risk category op

Risk Typec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RiskType

The type of risk associated with a medical device.
has sub-classes
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c, Software Risk c
is in domain of
is risk type of op
is in range of
has risk type op

Safety Alertc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SafetyAlert

A notification issued to inform users about potential safety issues related to a medical device.
has super-classes
Action Type c
has members
Safety_Alert_Type ni
is disjoint with
In Situ Correction c, Recall c, User Notice c

Self Test Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SelfTestDevice

A device intended to be able to be used by people without special knowledge.
has super-classes
Device Type c
has members
Self_Test_Device_Type ni
is disjoint with
Active Device c, Active Implant c, In Vitro Diagnostic Device c, Single Use Device c, Active Implant c, Implantable Device c, In Vitro Diagnostic Device c, Single Use Device c

Seriousc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Serious

A severity level indicating significant health impact or injury.
has super-classes
Severity Level c
has members
Serious_Sev ni
is disjoint with
Critical c, Moderate c

Serious Incidentc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SeriousIncident

An incident that led or could lead to serious deterioration of health or death.
has super-classes
Incident Type c
has members
Serious_Incident_Type ni
is disjoint with
Near Miss Incident c

Severity Levelc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SeverityLevel

The level of severity associated with a risk.
has sub-classes
Critical c, Moderate c, Serious c
is in domain of
is severity of op
is in range of
has severity op

Single Use Devicec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SingleUseDevice

A device intended to be used on one individual during a single procedure.
has super-classes
Device Type c
has members
Single_Use_Device_Type ni
is disjoint with
Active Device c, Active Implant c, In Vitro Diagnostic Device c, Self Test Device c, Active Implant c, Implantable Device c, In Vitro Diagnostic Device c, Self Test Device c

Software Riskc back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#SoftwareRisk

A risk caused by software errors, bugs, or failures in a medical device.
has super-classes
Risk Type c
has members
Software_Risk_Type ni
is disjoint with
Contamination Risk c, Cybersecurity Risk c, Diagnostic Risk c, Infection Risk c, Injury Risk c, Interference Risk c, Malfunction Risk c, Material Risk c, Radiation Risk c

User Noticec back to ToC or Class ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#UserNotice

A notification issued to users with instructions or information regarding the safe use of a medical device.
has super-classes
Action Type c
has members
User_Notice_Type ni
is disjoint with
In Situ Correction c, Recall c, Safety Alert c

Object Properties

affected device typeop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#affectedDeviceType_

Specifies the type of affected device.

has characteristics: functional, asymmetric, irreflexive

has domain
Risk c
has range
Device c
is inverse of
is affected type in op

has action typeop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasActionType

Specifies the type of corrective action.

has characteristics: functional, asymmetric, irreflexive

has domain
Corrective Action c
has range
Action Type c
is inverse of
is action type of op

has corrective actionop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasCorrectiveAction

Links an incident with its corrective action.

has characteristics: asymmetric, irreflexive

has domain
Incident c
has range
Corrective Action c
is inverse of
related to incident op

has device typeop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasDeviceType

The type of the device.

has characteristics: functional, asymmetric, irreflexive

has domain
Device c
has range
Device Type c
is inverse of
is device type of op

has incident recordedop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasIncidentRecorded

Links a device with its known incidents.

has characteristics: asymmetric, irreflexive

has domain
Device c
has range
Incident c
is inverse of
involves device op

has incident typeop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasIncidentType

Specifies the type of an incident.

has characteristics: functional, asymmetric, irreflexive

has domain
Incident c
has range
Incident Type c
is inverse of
is incident type of op

has manufacturerop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasManufacturer

Links a device to the manufacturer responsible for it.

has characteristics: functional, asymmetric, irreflexive

has domain
Device c
has range
Manufacturer c
is inverse of
is manufacturer of op

has probabilityop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasProbability

Indicates how likely a risk is to occur.

has characteristics: functional, asymmetric, irreflexive

has domain
Risk c
has range
Probability Level c
is inverse of
is probability of op

has reportedop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasReported

Relates an organization to the incidents they have reported.

has characteristics: asymmetric, irreflexive

has domain
Manufacturer c
has range
Incident c
is inverse of
reported by op

has riskop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasRisk

Associates an incident with a specific risk.

has characteristics: asymmetric, irreflexive

has domain
Incident c
has range
Risk c
is inverse of
is manifested in op

has risk categoryop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasRiskCategory

Specifies the category of a risk.

has characteristics: functional, asymmetric, irreflexive

has domain
Risk c
has range
Risk Category c
is inverse of
is risk category of op

has risk classop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasRiskClass

Defines the regulatory risk classification of a device.

has characteristics: functional, asymmetric, irreflexive

has domain
Device c
has range
Device Risk Class c
is inverse of
is risk class of op

has risk typeop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasRiskType

Specifies the type of risk.

has characteristics: functional, asymmetric, irreflexive

has domain
Risk c
has range
Risk Type c
is inverse of
is risk type of op

has severityop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#hasSeverity

Indicates the severity level of a risk.

has characteristics: functional, asymmetric, irreflexive

has domain
Risk c
has range
Severity Level c
is inverse of
is severity of op

involves deviceop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#involvesDevice

Associates an incident with the device involved.

has characteristics: functional, asymmetric, irreflexive

has domain
Incident c
has range
Device c
is inverse of
has incident recorded op

is action type ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isActionTypeOf

Links the type of a corrective measure to its actions.

has characteristics: asymmetric, irreflexive

has domain
Action Type c
has range
Corrective Action c
is inverse of
has action type op

is affected type inop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isAffectedTypeIn

Relates a device type to the incidents or actions that have affected that category.
has domain
Device c
has range
Risk c
is inverse of
affected device type op

is device type ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isDeviceTypeOf

Connects a device type to its medical devices.

has characteristics: asymmetric, irreflexive

has domain
Device Type c
has range
Device c
is inverse of
has device type op

is incident type ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isIncidentTypeOf

Links an incident type to the incidents.

has characteristics: asymmetric, irreflexive

has domain
Incident Type c
has range
Incident c
is inverse of
has incident type op

is manifested inop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isManifestedIn

Links a risk with its possible incidents.

has characteristics: asymmetric, irreflexive

has domain
Risk c
has range
Incident c
is inverse of
has risk op

is manufacturer ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isManufacturerOf

Links a manufacturer with its devices.

has characteristics: inverse functional, asymmetric, irreflexive

has domain
Manufacturer c
has range
Device c
is inverse of
has manufacturer op

is probability ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isProbabilityOf

Relates a probability level to a specific risk.

has characteristics: inverse functional, asymmetric, irreflexive

has domain
Probability Level c
has range
Risk c
is inverse of
has probability op

is risk category ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isRiskCategoryOf

Links a risk category its risks.

has characteristics: asymmetric, irreflexive

has domain
Risk Category c
has range
Risk c
is inverse of
has risk category op

is risk class ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isRiskClassOf

Relates a risk class to its devices.

has characteristics: asymmetric, irreflexive

has domain
Device Risk Class c
has range
Device c
is inverse of
has risk class op

is risk type ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isRiskTypeOf

Connects a risk type to the risks that have that type.

has characteristics: asymmetric, irreflexive

has domain
Risk Type c
has range
Risk c
is inverse of
has risk type op

is severity ofop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isSeverityOf

Connects a severity value with the risk that have its value.

has characteristics: inverse functional, asymmetric, irreflexive

has domain
Severity Level c
has range
Risk c
is inverse of
has severity op

related to incidentop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#relatedToIncident

Links a corrective action to the incident it addresses.

has characteristics: asymmetric, irreflexive

has domain
Corrective Action c
has range
Incident c
is inverse of
has corrective action op

reported byop back to ToC or Object Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#reportedBy

Indicates the manufacturer that reported the incident.

has characteristics: functional, asymmetric, irreflexive

has domain
Incident c
has range
Manufacturer c
is inverse of
has reported op

Data Properties

action datedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#actionDate

Date when the corrective action was initiated.

has characteristics: functional

has domain
Corrective Action c
has range
date

affected device typedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#affectedDeviceType

The type of the device related.

has characteristics: functional

has domain
Risk c
has range
string

authorization numberdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#authorizationNumber

Official authorization number assigned to a manufacturer.

has characteristics: functional

has domain
Manufacturer c
has range
string

closure datedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#closureDate

Date when the corrective action was completed.

has characteristics: functional

has domain
Corrective Action c
has range
date

competent authoritydp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#competentAuthority

Authority responsible for regulatory oversight.

has characteristics: functional

has domain
Manufacturer c
has range
string

corrective action takendp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#correctiveActionTaken

Indicates whether a corrective action has been taken in response to the incident.

has characteristics: functional

has domain
Incident c
has range
boolean

countries affecteddp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#countriesAffected

Countries impacted by the corrective action.
has domain
Corrective Action c
has range
string

countrydp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#country

Country where the manufacturer is located.

has characteristics: functional

has domain
Manufacturer c
has range
string

country reporteddp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#countryReported

The country where the incident was reported.

has characteristics: functional

has domain
Incident c
has range
string

descriptiondp back to ToC or Data Property ToC

IRI: http://purl.org/dc/terms/description

has domain
Corrective Action c or Incident c or Risk c
is also defined as
annotation property

detection datedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#detectionDate

The date when the incident or risk was first detected.

has characteristics: functional

has domain
Incident c
has range
date

device namedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#deviceName

The commercial name of the medical device.

has characteristics: functional

has domain
Device c
has range
string

devices affecteddp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#devicesAffected

Number of devices impacted.
has domain
Corrective Action c
has range
integer

emaildp back to ToC or Data Property ToC

IRI: https://schema.org/#email

The contact email address of the manufacturer.
has domain
Manufacturer c
has range
string

eudamed f s c a refdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#eudamedFSCARef

Reference identifier of the corrective action in EUDAMED.

has characteristics: functional

has domain
Corrective Action c
has range
string

eudamed incident refdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#eudamedIncidentRef

Reference identifier of the incident in EUDAMED.

has characteristics: functional

has domain
Incident c
has range
string

eudamed s r ndp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#eudamedSRN

Single Registration Number assigned in EUDAMED.

has characteristics: functional

has domain
Manufacturer c
has range
string

event datedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#eventDate

Date when the incident occurred.

has characteristics: functional

has domain
Incident c
has range
date

imdrf codedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#imdrfCode

Code assigned according to IMDRF risk classification.

has characteristics: functional

has domain
Risk c
has range
string

intended purposedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#intendedPurpose

The intended use of the device.

has characteristics: functional

has domain
Device c
has range
string

is activedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isActive

Indicates whether the device requires energy to operate.

has characteristics: functional

has domain
Device c
has range
boolean

is i v ddp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isIVD

Indicates whether the device is an in vitro diagnostic device.

has characteristics: functional

has domain
Device c
has range
boolean

is implantabledp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isImplantable

Indicates whether the device is implantable.

has characteristics: functional

has domain
Device c
has range
boolean

is reusabledp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#isReusable

Indicates whether the device can be reused.

has characteristics: functional

has domain
Device c
has range
boolean

namedp back to ToC or Data Property ToC

IRI: https://schema.org/#name

The official name of the manufacturer.

has characteristics: functional

has domain
Manufacturer c
has range
string

outcomedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#outcome

Result or consequence of the incident.

has characteristics: functional

has domain
Incident c
has range
string

patient agedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#patientAge

Age of the patient involved in the incident.

has characteristics: functional

has domain
Incident c
has range
integer

patient sexdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#patientSex

Sex of the patient involved.

has characteristics: functional

has domain
Incident c
has range
string

regulatory frameworkdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#regulatoryFramework

The regulatory framework under which the device is classified, MDR or IVDR.

has characteristics: functional

has domain
Device c
has range
string

report datedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#reportDate

Date when the incident was reported.

has characteristics: functional

has domain
Incident c
has range
date

risk namedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#riskName

Name describing the risk.

has characteristics: functional

has domain
Risk c
has range
string

scopedp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#scope

Scope of the corrective action.

has characteristics: functional

has domain
Corrective Action c
has range
string

statusdp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#status

Current status of the corrective action.

has characteristics: functional

has domain
Corrective Action c
has range
string

udi_didp back to ToC or Data Property ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#udi_di

The unique device identifier.

has characteristics: functional

has domain
Device c
has range
string

Named Individuals

Abbott Medical Devicesni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-002

Major manufacturer of cardiovascular and diabetes care devices.
belongs to
Manufacturer c
has facts
authorization number dp "DE/2017/005678"
competent authority dp "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"
country dp "Germany"
eudamed s r n dp "SRN-DE-MED-0002"
email dp "regulatory@abbott.com"
name dp "Abbott Medical Devices"

Active_Device_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Active_Device_Type

Device category used to define its use.
belongs to
Active Device c

Active_Implant_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Active_Implant_Type

Device category used to define its use.
belongs to
Active Implant c

ACUITY X4 Quadripolar LV Leadni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-005

Quadripolar LV lead for cardiac resynchronization therapy.
belongs to
Device c
has facts
has device type op Active_Implant_Type ni
has manufacturer op Boston Scientific Corporation ni
has risk class op Class_III ni
device name dp "ACUITY X4 Quadripolar LV Lead"
intended purpose dp "Cardiac resynchronization therapy lead"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)08714729004873"

ACUSON Sequoia Ultrasoundni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-007

High-performance diagnostic ultrasound imaging system.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Siemens Healthineers AG ni
has risk class op Class_IIa ni
device name dp "ACUSON Sequoia Ultrasound"
intended purpose dp "Diagnostic ultrasound imaging system"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04054839450001"

ATERA Mechanical Ventilatorni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-013

ICU mechanical ventilator with advanced ventilation modes.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Drägerwerk AG & Co. KGaA ni
has risk class op Class_IIb ni
device name dp "ATERA Mechanical Ventilator"
intended purpose dp "ICU mechanical ventilator with pressure and volume modes"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04046539001013"

BeneVision N1 Patient Monitorni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-022

Portable patient monitor for real-time vital signs tracking.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op GE HealthCare Technologies ni
has risk class op Class_IIa ni
device name dp "BeneVision N1 Patient Monitor"
intended purpose dp "Portable patient monitor for vital signs"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)07300000001022"

Biofilm formationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-008

Accumulation of bacterial biofilm on the implant surface.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op High_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Infection_Risk_Type ni
has severity op Moderate_Sev ni
imdrf code dp "A0402"
risk name dp "Biofilm formation"
description dp "Bacterial biofilm accumulation on implant surface resistant to antibiotics"

bioMérieux SAni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-015

World leader in the field of in vitro diagnostics.
belongs to
Manufacturer c
has facts
authorization number dp "FR/2017/002211"
competent authority dp "Agence nationale de sécurité du médicament (ANSM)"
country dp "France"
eudamed s r n dp "SRN-FR-MED-0015"
email dp "regulatory@biomerieux.com"
name dp "bioMérieux SA"

Biotronik SE & Co. KGni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-008

Specialist in cardio- and endovascular medical technology.
belongs to
Manufacturer c
has facts
authorization number dp "DE/2017/004567"
competent authority dp "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"
country dp "Germany"
eudamed s r n dp "SRN-DE-MED-0008"
email dp "regulatory@biotronik.com"
name dp "Biotronik SE & Co. KG"

Boston Scientific Corporationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-006

Manufacturer of medical devices used in interventional specialties.
belongs to
Manufacturer c
has facts
authorization number dp "IE/2017/002345"
competent authority dp "Health Products Regulatory Authority (HPRA)"
country dp "Ireland"
eudamed s r n dp "SRN-IE-MED-0006"
email dp "regulatory@bsci.com"
name dp "Boston Scientific Corporation"

Class_Ani back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_A

Standardized classification values for In Vitro Diagnostic (IVD) devices.
belongs to
Class A c

Class_Bni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_B

Standardized classification values for In Vitro Diagnostic (IVD) devices.
belongs to
Class B c

Class_Cni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_C

Standardized classification values for In Vitro Diagnostic (IVD) devices.
belongs to
Class C c

Class_Dni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_D

Standardized classification values for In Vitro Diagnostic (IVD) devices.
belongs to
Class D c

Class_Ini back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_I

Standardized risk classification values for General Medical Devices.
belongs to
Class I c

Class_IIani back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_IIa

Standardized risk classification values for General Medical Devices.
belongs to
Class I Ia c

Class_IIbni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_IIb

Standardized risk classification values for General Medical Devices.
belongs to
Class I Ib c

Class_IIIni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Class_III

Standardized risk classification values for General Medical Devices.
belongs to
Class I I I c

cobas e 801 Immunoassay Analyzerni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-016

Automated immunoassay analyzer for clinical laboratory use.
belongs to
Device c
has facts
has device type op In_Vitro_Diagnostic_Device_Type ni
has manufacturer op Roche Diagnostics GmbH ni
has risk class op Class_C ni
device name dp "cobas e 801 Immunoassay Analyzer"
intended purpose dp "Automated immunoassay analyzer for clinical laboratory"
is active dp "true"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)04015630001016"

cobas SARS-CoV-2 RT-PCR Testni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-017

Molecular diagnostic test kit for SARS-CoV-2 detection.
belongs to
Device c
has facts
has device type op In_Vitro_Diagnostic_Device_Type ni
has manufacturer op Roche Diagnostics GmbH ni
has risk class op Class_C ni
device name dp "cobas SARS-CoV-2 RT-PCR Test"
intended purpose dp "Molecular diagnostic test for SARS-CoV-2 detection"
is active dp "false"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)04015630001017"

Contamination_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Contamination_Risk_Type

Instance used to specify the hazard.
belongs to
Contamination Risk c

Critical_Sevni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Critical_Sev

Value used to show severity.
belongs to
Critical c

Cybersecurity vulnerabilityni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-018

Software vulnerability allowing unauthorized device access.
belongs to
Risk c
has facts
affected device type op Active_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Safety_Cat ni
has risk type op Cybersecurity_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "B0401"
risk name dp "Cybersecurity vulnerability"
description dp "Exploitable software vulnerability enabling unauthorized device access"

Cybersecurity_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Cybersecurity_Risk_Type

Instance used to specify the hazard.
belongs to
Cybersecurity Risk c

Device thrombosisni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-003

Potential for thrombus formation on blood-contacting surfaces.
belongs to
Risk c
has facts
affected device type op Implantable_Active_Type ni
has probability op Low_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Injury_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0201"
risk name dp "Thrombosis - device-related"
description dp "Thrombus formation on device surface causing embolic events"

Device-related infectionni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-007

Risk of infection or sepsis related to the medical device.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op Medium_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Infection_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "A0401"
risk name dp "Infection - device-related"
description dp "Device-related infection at implantation site or systemic sepsis"

Device_Failure_Catni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Device_Failure_Cat

Instance used to group risks by their area of impact.
belongs to
Device Failure c

Device_Performance_Catni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Device_Performance_Cat

Instance used to group risks by their area of impact.
belongs to
Device Performance c

Device_Safety_Catni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Device_Safety_Cat

Instance used to group risks by their area of impact.
belongs to
Device Safety c

Diagnostic_Error_Catni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Diagnostic_Error_Cat

Instance used to group risks by their area of impact.
belongs to
Diagnostic Error c

Diagnostic_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Diagnostic_Risk_Type

Instance used to specify the hazard.
belongs to
Diagnostic Risk c

Drägerwerk AG & Co. KGaAni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-012

International leader in medical and safety technology.
belongs to
Manufacturer c
has facts
authorization number dp "DE/2017/005566"
competent authority dp "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"
country dp "Germany"
eudamed s r n dp "SRN-DE-MED-0012"
email dp "regulatory@draeger.com"
name dp "Drägerwerk AG & Co. KGaA"

Electrical failureni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-001

Risk of complete electrical shutdown of the device.
belongs to
Risk c
has facts
affected device type op Active_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Failure_Cat ni
has risk type op Malfunction_Rick_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0101"
risk name dp "Device_Failure_Cat - electrical"
description dp "Complete loss of electrical function leading to device shutdown"

Electromagnetic interferenceni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-013

External EMI interference affecting active implant functions.
belongs to
Risk c
has facts
affected device type op Active_Implant_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Performance_Cat ni
has risk type op Interference_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "A0702"
risk name dp "Electromagnetic interference"
description dp "External EMI affecting pacemaker/ICD sensing and pacing functions"

False negative diagnosticni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-015

Diagnostic risk of failing to detect a target condition.
belongs to
Risk c
has facts
affected device type op In_Vitro_Diagnostic_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Diagnostic_Error_Cat ni
has risk type op Diagnostic_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "B0102"
risk name dp "False negative result"
description dp "IVD test fails to detect target condition in affected individual"

False positive diagnosticni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-014

Diagnostic risk of reporting a condition when none is present.
belongs to
Risk c
has facts
affected device type op In_Vitro_Diagnostic_Device_Type ni
has probability op Medium_Probability_Type ni
has risk category op Diagnostic_Error_Cat ni
has risk type op Diagnostic_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "B0101"
risk name dp "False positive result"
description dp "IVD test returns positive result in absence of target condition"

FSCA-001 (Safety Alert)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-001

Safety alert regarding anticoagulation protocol updates.
belongs to
Corrective Action c
has facts
has action type op Safety_Alert_Type ni
related to incident op Incident INC-001 (Embolic stroke) ni
action date dp "2024-02-01"^^date
countries affected dp "EU-wide"
devices affected dp "850"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000001"
scope dp "All HeartMate 3 LVAD units implanted since 2020"
status dp "Open"
description dp "Safety_Alert_Type issued to all implanting centres regarding anticoagulation protocol update for HeartMate 3 to reduce device thrombosis risk. INR target range revised to 2.0–3.0."

FSCA-002 (Recall)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-002

Voluntary recall of specific lots due to battery issues.
belongs to
Corrective Action c
has facts
has action type op Recall_Type ni
related to incident op Incident INC-002 (Battery depletion) ni
action date dp "2024-02-28"^^date
closure date dp "2024-05-31"^^date
countries affected dp "EU-wide + UK"
devices affected dp "1240"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000002"
scope dp "Micra AV lots manufactured between 2022-09 and 2023-03"
status dp "Closed"
description dp "Voluntary Recall_Type of affected Micra AV lots due to premature battery depletion. Replacement units provided. 97% of affected devices successfully replaced."

FSCA-003 (In Situ Correction)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-003

Field correction involving updated implantation techniques.
belongs to
Corrective Action c
has facts
has action type op In_Situ_Correction_Type ni
related to incident op Incident INC-003 (Valve migration) ni
action date dp "2024-03-15"^^date
closure date dp "2024-06-30"^^date
countries affected dp "EU-wide"
devices affected dp "320"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000003"
scope dp "Portico THV sizes 23mm and 25mm from lots before 2023-11"
status dp "Closed"
description dp "Enhanced deployment training and updated IFU for Portico valve implantation technique. New implantation checklist mandatory for all TAVI centres."

FSCA-004 (Safety Alert)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-004

Communication on optimal fixation techniques for cardiac leads.
belongs to
Corrective Action c
has facts
has action type op Safety_Alert_Type ni
related to incident op Incident INC-005 (Lead dislodgement) ni
action date dp "2024-04-10"^^date
countries affected dp "EU-wide"
devices affected dp "2100"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000004"
scope dp "All ACUITY X4 quadripolar LV leads"
status dp "Open"
description dp "Safety communication to implanting cardiologists regarding optimal fixation technique for ACUITY X4 lead. Enhanced fluoroscopy verification protocol at implantation."

FSCA-005 (In Situ Correction)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-005

Enhanced surveillance programme for patients with joint implants.
belongs to
Corrective Action c
has facts
has action type op In_Situ_Correction_Type ni
related to incident op Incident INC-007 (Tissue reaction) ni
action date dp "2024-05-20"^^date
closure date dp "2024-09-30"^^date
countries affected dp "EU-wide + Switzerland"
devices affected dp "780"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000005"
scope dp "Persona Knee tibial inserts with lot numbers PN-2019-* to PN-2021-*"
status dp "Closed"
description dp "Enhanced surveillance programme: annual DEXA scan and serum particle monitoring for patients with affected tibial inserts. Patients contacted individually."

FSCA-006 (Recall)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-006

Urgent recall of hip implants due to metal ion release.
belongs to
Corrective Action c
has facts
has action type op Recall_Type ni
related to incident op Incident INC-008 (Cobalt toxicity) ni
action date dp "2024-05-30"^^date
countries affected dp "EU-wide"
devices affected dp "540"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000006"
scope dp "TRITON Total Hip ceramic-on-ceramic 28mm heads from lots TH-2020-* and TH-2021-*"
status dp "Open"
description dp "Urgent safety Recall_Type due to elevated metal ion levels. Revision surgery recommended for patients with serum cobalt >7 ppb or symptomatic ALTR. Replacement implants provided."

FSCA-007 (User Notice)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-007

Safety notice regarding updated MRI-conditional guidelines.
belongs to
Corrective Action c
has facts
has action type op User_Notice_Type ni
related to incident op Incident INC-009 (Inappropriate shock) ni
action date dp "2024-05-25"^^date
closure date dp "2024-07-31"^^date
countries affected dp "EU-wide + UK"
devices affected dp "4300"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000007"
scope dp "All Viva CRT-D devices"
status dp "Closed"
description dp "Urgent safety notice regarding MRI scanning protocol. Updated MRI-conditional guidelines issued. Mandatory reprogramming required before any MRI scan. Programmer software update v3.2 released."

FSCA-008 (Recall)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-008

Mandatory software update to correct ventilator calibration.
belongs to
Corrective Action c
has facts
has action type op Recall_Type ni
related to incident op Incident INC-009 (Inappropriate shock) ni
action date dp "2024-06-05"^^date
closure date dp "2024-08-15"^^date
countries affected dp "EU-wide"
devices affected dp "180"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000008"
scope dp "ATERA ventilators with software version 2.1.3"
status dp "Closed"
description dp "Software Recall_Type: mandatory update to version 2.2.0 resolving FiO2 calibration error. Biomedical engineers visited all affected units within 14 days. Field service documentation required."

FSCA-009 (User Notice)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-009

Field notification regarding interference screening in assays.
belongs to
Corrective Action c
has facts
has action type op User_Notice_Type ni
related to incident op Incident INC-011 (False positive TSH) ni
action date dp "2024-06-20"^^date
closure date dp "2024-09-30"^^date
countries affected dp "EU-wide"
devices affected dp "620"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000009"
scope dp "All cobas e 801 immunoassay analysers"
status dp "Closed"
description dp "Customer field notification regarding biotin interference in TSH assay. Updated sample preparation protocol and interference screening algorithm released via software update 4.1.2."

FSCA-010 (Recall)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-010

Immediate quarantine and replacement of diagnostic reagent lots.
belongs to
Corrective Action c
has facts
has action type op Recall_Type ni
related to incident op Incident INC-012 (False negative SARS-CoV-2) ni
action date dp "2024-06-30"^^date
closure date dp "2024-08-31"^^date
countries affected dp "EU-wide + Norway + Iceland"
devices affected dp "12500"^^decimal
eudamed f s c a ref dp "EU-FSCA-2024-000010"
scope dp "cobas SARS-CoV-2 RT-PCR reagent lot numbers CV-2024-0312 to CV-2024-0318"
status dp "Closed"
description dp "Immediate quarantine and replacement of affected reagent lots. Reflex testing protocol issued. All positive results from affected lots to be re-confirmed. New primer design covering BA.2.86 released."

FSCA-011 (In Situ Correction)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-011

Mandatory firmware update to improve sensor compensation.
belongs to
Corrective Action c
has facts
has action type op In_Situ_Correction_Type ni
related to incident op Incident INC-014 (Hyperglycaemic event) ni
action date dp "2024-08-01"^^date
countries affected dp "EU-wide"
devices affected dp "3200"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000011"
scope dp "All OPTIGA CGM sensors from manufacturing site GE-SGP-2"
status dp "Open"
description dp "Enhanced calibration protocol issued. Firmware update v1.8.5 mandatory improving temperature compensation algorithm. Patients instructed to perform confirmatory finger-stick at glucose readings <4.5 or >13.9 mmol/L."

FSCA-012 (Recall)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-012

Urgent recall and software update for infusion pump drug library.
belongs to
Corrective Action c
has facts
has action type op Recall_Type ni
related to incident op Incident INC-015 (Drug overdose) ni
action date dp "2024-08-20"^^date
closure date dp "2024-10-31"^^date
countries affected dp "EU-wide + UK + Norway"
devices affected dp "2870"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000012"
scope dp "Plum 360 infusion pumps with drug library version 4.2.1"
status dp "Closed"
description dp "Urgent Recall_Type and remote software update. Drug library version 4.3.0 deployed correcting decimal point error. All units verified by biomedical engineering before return to clinical use."

FSCA-013 (Safety Alert)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-013

Communication regarding outflow graft routing techniques.
belongs to
Corrective Action c
has facts
has action type op Safety_Alert_Type ni
related to incident op Incident INC-016 (Haemolytic anaemia) ni
action date dp "2024-09-10"^^date
countries affected dp "EU-wide"
devices affected dp "420"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000013"
scope dp "All HeartMate 3 LVAD units with outflow graft lot OG-2022-*"
status dp "Open"
description dp "Safety communication regarding outflow graft kinking risk. Updated surgical technique for graft routing issued. Mandatory follow-up CT at 6 months for patients with affected lot numbers."

FSCA-014 (User Notice)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-014

Updated clinical protocol for infection prophylaxis.
belongs to
Corrective Action c
has facts
has action type op User_Notice_Type ni
related to incident op Incident INC-017 (Endophthalmitis) ni
action date dp "2024-09-25"^^date
closure date dp "2024-12-31"^^date
countries affected dp "EU-wide"
devices affected dp "1100"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000014"
scope dp "All Iluvien intravitreal implants"
status dp "Closed"
description dp "Updated IFU regarding post-operative infection prophylaxis protocol. Extended topical antibiotic course (14 days) mandatory post-insertion. Healthcare professionals notified via direct mail and implanting centre visits."

FSCA-015 (In Situ Correction)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#FSCA-015

Deployment of security patch to disable unauthorized access.
belongs to
Corrective Action c
has facts
has action type op In_Situ_Correction_Type ni
related to incident op Incident INC-018 (Cybersecurity vulnerability) ni
action date dp "2024-10-01"^^date
countries affected dp "EU-wide"
devices affected dp "890"^^integer
eudamed f s c a ref dp "EU-FSCA-2024-000015"
scope dp "All 5008S hemodialysis machines with network connectivity module v2.x"
status dp "Open"
description dp "Security patch 3.0.1 mandatory deployment disabling unrestricted web interface access. Network segmentation guidance issued to hospital IT departments. Penetration test report provided to competent authorities."

GE HealthCare Technologiesni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-009

Provider of medical imaging, monitoring, and digital solutions.
belongs to
Manufacturer c
has facts
authorization number dp "SE/2017/008901"
competent authority dp "Läkemedelsverket (MPA)"
country dp "Sweden"
eudamed s r n dp "SRN-SE-MED-0009"
email dp "regulatory@gehealthcare.com"
name dp "GE HealthCare Technologies"

Harmony Prenatal Testni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-020

Non-invasive prenatal test for detecting genetic aneuploidies.
belongs to
Device c
has facts
has device type op In_Vitro_Diagnostic_Device_Type ni
has manufacturer op Abbott Medical Devices ni
has risk class op Class_D ni
device name dp "Harmony Prenatal Test"
intended purpose dp "Non-invasive prenatal testing (NIPT) for aneuploidies"
is active dp "false"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)00800002001020"

HeartMate 3 LVADni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-001

Ventricular assist device for end-stage heart failure treatment.
belongs to
Device c
has facts
has device type op Implantable_Active_Type ni
has manufacturer op Medtronic plc ni
has risk class op Class_III ni
device name dp "HeartMate 3 LVAD"
intended purpose dp "Ventricular assist device for end-stage heart failure"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)00380740009095"

Hemodialysis Machine 5008Sni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-015

High-volume online hemodiafiltration machine for renal care.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Nipro Corporation ni
has risk class op Class_IIb ni
device name dp "Hemodialysis Machine 5008S"
intended purpose dp "High-volume online hemodiafiltration machine"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04547597001015"

High_Probability_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#High_Probability_Type

Value used to show likelihood.
belongs to
High c

Hologic Inc.ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-014

Medical technology company primarily focused on women's health.
belongs to
Manufacturer c
has facts
authorization number dp "BE/2017/009900"
competent authority dp "Agence fédérale des médicaments et des produits de santé (AFMPS)"
country dp "Belgium"
eudamed s r n dp "SRN-BE-MED-0014"
email dp "regulatory@hologic.com"
name dp "Hologic Inc."

Iluvien Intravitreal Implantni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-011

Sustained-release intravitreal implant for ocular therapy.
belongs to
Device c
has facts
has device type op Active_Implant_Type ni
has manufacturer op LivaNova PLC ni
has risk class op Class_III ni
device name dp "Iluvien Intravitreal Implant"
intended purpose dp "Sustained-release fluocinolone acetonide ocular implant"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)05391520001011"

Implant migrationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-005

Unintended migration of an implant from its original site.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Performance_Cat ni
has risk type op Malfunction_Rick_Type ni
has severity op Serious_Sev ni
imdrf code dp "A0301"
risk name dp "Device migration - implant"
description dp "Unintended displacement of implant from intended anatomical position"

Implantable_Active_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Implantable_Active_Type

Device category used to define its use.
belongs to
Implantable Active Device c

Implantable_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Implantable_Type

Device category used to define its use.
belongs to
Implantable Device c

In_Situ_Correction_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#In_Situ_Correction_Type

Represents the specific action of performing repairs or adjustments at the device's location.
belongs to
In Situ Correction c

In_Vitro_Diagnostic_Device_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#In_Vitro_Diagnostic_Device_Type

Device category used to define its use.
belongs to
In Vitro Diagnostic Device c

Incident INC-001 (Embolic stroke)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-001

Serious injury involving embolic stroke and device thrombus.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Device thrombosis ni
involves device op HeartMate 3 LVAD ni
reported by op Medtronic plc ni
corrective action taken dp "true"^^boolean
country reported dp "Germany"
detection date dp "2024-01-10"^^date
eudamed incident ref dp "EU-INC-2024-000001"
event date dp "2024-01-08"^^date
outcome dp "Serious_Sev patient injury - embolic stroke"
patient age dp "58"^^integer
patient sex dp "Male"
report date dp "2024-01-15"^^date
description dp "Patient implanted with HeartMate 3 LVAD developed ischemic stroke 6 months post-implant. Device thrombus confirmed by echocardiography."

Incident INC-002 (Battery depletion)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-002

Malfunction report regarding premature battery depletion.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Premature battery depletion ni
involves device op Micra AV Transcatheter Pacing System ni
reported by op Medtronic plc ni
corrective action taken dp "true"^^boolean
country reported dp "France"
detection date dp "2024-02-01"^^date
eudamed incident ref dp "EU-INC-2024-000002"
event date dp "2024-01-29"^^date
outcome dp "Device malfunction - premature battery depletion"
patient age dp "72"^^integer
patient sex dp "Female"
report date dp "2024-02-03"^^date
description dp "Micra AV pacemaker reached elective replacement indicator 14 months earlier than expected longevity specification."

Incident INC-003 (Valve migration)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-003

Surgical intervention required due to valve migration.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Implant migration ni
involves device op Portico Transcatheter Heart Valve ni
reported by op Abbott Medical Devices ni
corrective action taken dp "true"^^boolean
country reported dp "Italy"
detection date dp "2024-02-18"^^date
eudamed incident ref dp "EU-INC-2024-000003"
event date dp "2024-02-15"^^date
outcome dp "Surgical intervention required - valve re-anchoring"
patient age dp "67"^^integer
patient sex dp "Male"
report date dp "2024-02-20"^^date
description dp "Portico valve showed paravalvular leak grade III due to partial migration 2 weeks post-TAVI procedure."

Incident INC-004 (Stent fracture)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-004

Detection of stent fracture causing in-stent restenosis.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Mechanical failure ni
involves device op SYNERGY Stent System ni
reported by op Boston Scientific Corporation ni
corrective action taken dp "false"^^boolean
country reported dp "Spain"
detection date dp "2024-03-03"^^date
eudamed incident ref dp "EU-INC-2024-000004"
event date dp "2024-02-28"^^date
outcome dp "Device malfunction - stent fracture"
patient age dp "55"^^integer
patient sex dp "Female"
report date dp "2024-03-05"^^date
description dp "SYNERGY stent fracture detected on angiography 18 months post-implant causing in-stent restenosis."

Incident INC-005 (Lead dislodgement)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-005

Incident involving lead dislodgement requiring repositioning.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Lead dislodgement ni
involves device op ACUITY X4 Quadripolar LV Lead ni
reported by op Boston Scientific Corporation ni
corrective action taken dp "true"^^boolean
country reported dp "Netherlands"
detection date dp "2024-03-16"^^date
eudamed incident ref dp "EU-INC-2024-000005"
event date dp "2024-03-12"^^date
outcome dp "Surgical intervention required - lead extraction"
patient age dp "63"^^integer
patient sex dp "Male"
report date dp "2024-03-18"^^date
description dp "ACUITY X4 lead dislodgement to right ventricle requiring fluoroscopy-guided repositioning."

Incident INC-006 (System failure)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-006

Complete system failure during patient ultrasound examination.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Electrical failure ni
involves device op ACUSON Sequoia Ultrasound ni
reported by op Siemens Healthineers AG ni
corrective action taken dp "false"^^boolean
country reported dp "Belgium"
detection date dp "2024-04-01"^^date
eudamed incident ref dp "EU-INC-2024-000006"
event date dp "2024-04-01"^^date
outcome dp "Device malfunction - complete system failure"
patient sex dp "N/A"
report date dp "2024-04-02"^^date
description dp "ACUSON Sequoia ultrasound system froze mid-examination. Emergency shutdown required; patient examination incomplete."

Incident INC-007 (Tissue reaction)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-007

Adverse tissue reaction caused by accelerated component wear.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Joint wear debris ni
involves device op Persona Knee System ni
reported by op Zimmer Biomet Holdings ni
corrective action taken dp "true"^^boolean
country reported dp "Sweden"
detection date dp "2024-04-10"^^date
eudamed incident ref dp "EU-INC-2024-000007"
event date dp "2024-03-01"^^date
outcome dp "Patient_Harm_Cat - adverse tissue reaction"
patient age dp "70"^^integer
patient sex dp "Male"
report date dp "2024-04-14"^^date
description dp "Persona knee tibial insert showing accelerated polyethylene wear with metallosis confirmed at 3-year revision surgery."

Incident INC-008 (Cobalt toxicity)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-008

Report of cobalt toxicity and local tissue reaction.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Metallic corrosion ni
involves device op TRITON Total Hip System ni
reported by op Stryker Corporation ni
corrective action taken dp "true"^^boolean
country reported dp "Denmark"
detection date dp "2024-04-25"^^date
eudamed incident ref dp "EU-INC-2024-000008"
event date dp "2024-04-20"^^date
outcome dp "Patient_Harm_Cat - cobalt toxicity"
patient age dp "65"^^integer
patient sex dp "Female"
report date dp "2024-04-28"^^date
description dp "TRITON hip patient presented with elevated serum cobalt (18 ppb). Adverse local tissue reaction (ALTR) confirmed by MRI."

Incident INC-009 (Inappropriate shock)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-009

Inappropriate ICD shock delivery during MRI procedure.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Electromagnetic interference ni
involves device op Viva Cardiac Resynchronization Defibrillator ni
reported by op Biotronik SE & Co. KG ni
corrective action taken dp "true"^^boolean
country reported dp "Poland"
detection date dp "2024-05-04"^^date
eudamed incident ref dp "EU-INC-2024-000009"
event date dp "2024-05-03"^^date
outcome dp "Inappropriate shock delivery"
patient age dp "68"^^integer
patient sex dp "Male"
report date dp "2024-05-06"^^date
description dp "Viva CRT-D delivered inappropriate ICD therapy during MRI scan despite MRI-conditional programming. Patient experienced pain and syncope."

Incident INC-009 (Inappropriate shock)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-010

Ventilator software error causing incorrect FiO2 delivery.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Software malfunction ni
involves device op ATERA Mechanical Ventilator ni
reported by op Drägerwerk AG & Co. KGaA ni
corrective action taken dp "true"^^boolean
country reported dp "Germany"
detection date dp "2024-05-19"^^date
eudamed incident ref dp "EU-INC-2024-000010"
event date dp "2024-05-19"^^date
outcome dp "Device malfunction - incorrect FiO2 delivery"
patient sex dp "N/A"
report date dp "2024-05-20"^^date
description dp "ATERA ventilator software version 2.1.3 delivered FiO2 6% lower than set value for patients in ARDS protocol. 3 patients affected."

Incident INC-011 (False positive TSH)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-011

False positive results in TSH assay due to interference.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op False positive diagnostic ni
involves device op cobas e 801 Immunoassay Analyzer ni
reported by op Roche Diagnostics GmbH ni
corrective action taken dp "true"^^boolean
country reported dp "France"
detection date dp "2024-06-01"^^date
eudamed incident ref dp "EU-INC-2024-000011"
event date dp "2024-05-28"^^date
outcome dp "Diagnostic_Error_Cat - false positive TSH results"
patient sex dp "N/A"
report date dp "2024-06-03"^^date
description dp "cobas e 801 thyroid-stimulating hormone (TSH) assay reported false positive results (>10 mIU/L) in 12 euthyroid patients due to biotin interference."

Incident INC-012 (False negative SARS-CoV-2)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-012

False negative results failing to detect SARS-CoV-2 subvariant.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op False negative diagnostic ni
involves device op cobas SARS-CoV-2 RT-PCR Test ni
reported by op Roche Diagnostics GmbH ni
corrective action taken dp "true"^^boolean
country reported dp "Spain"
detection date dp "2024-06-13"^^date
eudamed incident ref dp "EU-INC-2024-000012"
event date dp "2024-06-10"^^date
outcome dp "Diagnostic_Error_Cat - false negative SARS-CoV-2"
patient sex dp "N/A"
report date dp "2024-06-15"^^date
description dp "cobas SARS-CoV-2 assay failed to detect Omicron BA.2.86 subvariant in 7 samples confirmed positive by sequencing. Lot-specific issue."

Incident INC-013 (False negative HIV)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-013

Missed detection of HIV-1 group O during seroconversion.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op False negative diagnostic ni
involves device op VIDAS HIV DUO Ultra ni
reported by op bioMérieux SA ni
corrective action taken dp "false"^^boolean
country reported dp "Germany"
detection date dp "2024-06-29"^^date
eudamed incident ref dp "EU-INC-2024-000013"
event date dp "2024-06-25"^^date
outcome dp "Diagnostic_Error_Cat - false negative HIV"
patient sex dp "N/A"
report date dp "2024-07-01"^^date
description dp "VIDAS HIV DUO Ultra failed to detect HIV-1 group O infection in seroconversion panel. Patient missed early treatment window."

Incident INC-014 (Hyperglycaemic event)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-014

Hyperglycaemic event caused by incorrect CGM glucose reading.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op False positive diagnostic ni
involves device op OPTIGA Glucose Monitoring System ni
reported by op GE HealthCare Technologies ni
corrective action taken dp "true"^^boolean
country reported dp "Netherlands"
detection date dp "2024-07-15"^^date
eudamed incident ref dp "EU-INC-2024-000014"
event date dp "2024-07-10"^^date
outcome dp "Patient_Harm_Cat - hyperglycaemic event"
patient age dp "45"^^integer
patient sex dp "Female"
report date dp "2024-07-18"^^date
description dp "OPTIGA CGM sensor reported glucose 3.8 mmol/L while laboratory reference showed 14.2 mmol/L. Patient delayed insulin administration."

Incident INC-015 (Drug overdose)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-015

Critical drug overdose due to software decimal point error.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Software malfunction ni
involves device op Infusion Pump Plum 360 ni
reported by op Abbott Medical Devices ni
corrective action taken dp "true"^^boolean
country reported dp "Italy"
detection date dp "2024-08-04"^^date
eudamed incident ref dp "EU-INC-2024-000015"
event date dp "2024-08-04"^^date
outcome dp "Patient_Harm_Cat - drug overdose"
patient age dp "81"^^integer
patient sex dp "Female"
report date dp "2024-08-05"^^date
description dp "Plum 360 infusion pump delivered 10x heparin dose due to software decimal point error in drug library version 4.2.1."

Incident INC-016 (Haemolytic anaemia)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-016

Severe haemolysis associated with device graft kinking.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Pump-induced hemolysis ni
involves device op HeartMate 3 LVAD ni
reported by op Medtronic plc ni
corrective action taken dp "true"^^boolean
country reported dp "United Kingdom"
detection date dp "2024-08-18"^^date
eudamed incident ref dp "EU-INC-2024-000016"
event date dp "2024-08-15"^^date
outcome dp "Patient_Harm_Cat - haemolytic anaemia"
patient age dp "52"^^integer
patient sex dp "Male"
report date dp "2024-08-20"^^date
description dp "HeartMate 3 patient developed severe haemolysis (LDH >2000 U/L) associated with outflow graft kinking confirmed by CT."

Incident INC-017 (Endophthalmitis)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-017

Device-related endophthalmitis requiring implant removal.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Device-related infection ni
involves device op Iluvien Intravitreal Implant ni
reported by op LivaNova PLC ni
corrective action taken dp "true"^^boolean
country reported dp "France"
detection date dp "2024-08-30"^^date
eudamed incident ref dp "EU-INC-2024-000017"
event date dp "2024-08-25"^^date
outcome dp "Surgical intervention - implant removal"
patient age dp "54"^^integer
patient sex dp "Female"
report date dp "2024-09-02"^^date
description dp "Iluvien implant required surgical removal due to device-related endophthalmitis confirmed by vitreous culture."

Incident INC-018 (Cybersecurity vulnerability)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-018

Cybersecurity vulnerability exposing device network interface.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Cybersecurity vulnerability ni
involves device op Hemodialysis Machine 5008S ni
reported by op Nipro Corporation ni
corrective action taken dp "true"^^boolean
country reported dp "Germany"
detection date dp "2024-09-14"^^date
eudamed incident ref dp "EU-INC-2024-000018"
event date dp "2024-09-12"^^date
outcome dp "Cybersecurity incident - unauthorised access"
patient sex dp "N/A"
report date dp "2024-09-15"^^date
description dp "5008S hemodialysis machine web interface exposed to hospital internal network. Unauthorised session accessed alarm configuration."

Incident INC-019 (Activation failure)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-019

Near-miss incident involving cochlear implant activation failure.
belongs to
Incident c
has facts
has incident type op Near_Miss_Incident_Type ni
has risk op Electrical failure ni
involves device op Tivoli II Cochlear Implant ni
reported by op Biotronik SE & Co. KG ni
corrective action taken dp "false"^^boolean
country reported dp "Sweden"
detection date dp "2024-09-30"^^date
eudamed incident ref dp "EU-INC-2024-000019"
event date dp "2024-09-28"^^date
outcome dp "Near-miss - device not activated post-surgery"
patient age dp "71"^^integer
patient sex dp "Male"
report date dp "2024-10-01"^^date
description dp "Tivoli II cochlear implant failed to respond to initial activation programming. Sound processor replacement resolved the issue."

Incident INC-020 (SAR heating injury)ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#INC-020

Localised skin burn during MRI scan due to SAR heating.
belongs to
Incident c
has facts
has incident type op Serious_Incident_Type ni
has risk op Radiation overdose ni
involves device op MAGNETOM Vida MRI System ni
reported by op Siemens Healthineers AG ni
corrective action taken dp "false"^^boolean
country reported dp "Belgium"
detection date dp "2024-10-12"^^date
eudamed incident ref dp "EU-INC-2024-000020"
event date dp "2024-10-10"^^date
outcome dp "Patient_Harm_Cat - SAR heating injury"
patient age dp "38"^^integer
patient sex dp "Female"
report date dp "2024-10-14"^^date
description dp "MAGNETOM Vida MRI caused localised skin burn (1st degree) at anterior electrode lead in patient with DBS system not declared prior to scan."

Infection_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Infection_Risk_Type

Instance used to specify the hazard.
belongs to
Infection Risk c

Infusion Pump Plum 360ni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-024

Large volume infusion pump with integrated drug library.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Abbott Medical Devices ni
has risk class op Class_IIb ni
device name dp "Infusion Pump Plum 360"
intended purpose dp "Large volume infusion pump with drug library"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)00800002001024"

Injury_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Injury_Risk_Type

Instance used to specify the hazard.
belongs to
Injury Risk c

Interference_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Interference_Risk_Type

Instance used to specify the hazard.
belongs to
Interference Risk c

Joint wear debrisni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-019

Tissue reaction caused by particulate debris from implants.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op Medium_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Material_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "C0101"
risk name dp "Wear debris - joint implant"
description dp "Particulate debris from bearing surfaces causing adverse tissue reaction"

Lead dislodgementni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-006

Potential for cardiac lead displacement post-implantation.
belongs to
Risk c
has facts
affected device type op Active_Implant_Type ni
has probability op Medium_Probability_Type ni
has risk category op Device_Performance_Cat ni
has risk type op Malfunction_Rick_Type ni
has severity op Serious_Sev ni
imdrf code dp "A0302"
risk name dp "Lead dislodgement"
description dp "Cardiac lead displacement requiring repositioning or replacement"

LivaNova PLCni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-011

Medical device company focused on cardiac surgery and neuromodulation.
belongs to
Manufacturer c
has facts
authorization number dp "UK/2017/003344"
competent authority dp "Medicines and Healthcare products Regulatory Agency (MHRA)"
country dp "United Kingdom"
eudamed s r n dp "SRN-UK-MED-0011"
email dp "regulatory@livanova.com"
name dp "LivaNova PLC"

Low_Probability_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Low_Probability_Type

Value used to show likelihood.
belongs to
Low c

Lumify Portable Ultrasoundni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-014

Handheld point-of-care ultrasound diagnostic probe.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Philips Medical Systems ni
has risk class op Class_IIa ni
device name dp "Lumify Portable Ultrasound"
intended purpose dp "Handheld point-of-care ultrasound probe"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)08718998001014"

MAGNETOM Vida MRI Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-008

3T magnetic resonance imaging system for advanced diagnostics.
belongs to
Device c
has facts
has device type op Active_Device_Type ni
has manufacturer op Siemens Healthineers AG ni
has risk class op Class_IIa ni
device name dp "MAGNETOM Vida MRI System"
intended purpose dp "Magnetic resonance imaging system 3T"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04054839460002"

Malfunction_Rick_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Malfunction_Rick_Type

Instance used to specify the hazard.
belongs to
Malfunction Risk c

Material_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Material_Risk_Type

Instance used to specify the hazard.
belongs to
Material Risk c

Mechanical failureni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-002

Risk of structural mechanical failure under physiological load.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op Medium_Probability_Type ni
has risk category op Device_Failure_Cat ni
has risk type op Malfunction_Rick_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0102"
risk name dp "Device_Failure_Cat - mechanical"
description dp "Structural failure of mechanical components under physiological load"

Medium_Probability_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Medium_Probability_Type

Value used to show likelihood.
belongs to
Medium c

Medtronic plcni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-001

Global medical technology company based in Ireland.
belongs to
Manufacturer c
has facts
authorization number dp "IE/2017/001234"
competent authority dp "Health Products Regulatory Authority (HPRA)"
country dp "Ireland"
eudamed s r n dp "SRN-IE-MED-0001"
email dp "regulatory@medtronic.com"
name dp "Medtronic plc"

Metallic corrosionni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-020

Local or systemic toxicity due to metallic ion corrosion.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op Low_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Material_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "C0201"
risk name dp "Corrosion - metallic implant"
description dp "Metallic ion release from corrosion causing local or systemic toxicity"

Micra AV Transcatheter Pacing Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-002

Leadless cardiac pacemaker designed for atrioventricular synchrony.
belongs to
Device c
has facts
has device type op Active_Implant_Type ni
has manufacturer op Medtronic plc ni
has risk class op Class_III ni
device name dp "Micra AV Transcatheter Pacing System"
intended purpose dp "Leadless cardiac pacemaker for atrioventricular synchrony"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)00380740009112"

Moderate_Sevni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Moderate_Sev

Value used to show severity.
belongs to
Moderate c

MRI metallic artifactni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-012

Formation of MRI artifacts compromising diagnostic quality.
belongs to
Risk c
has facts
affected device type op Implantable_Type ni
has probability op High_Probability_Type ni
has risk category op Device_Performance_Cat ni
has risk type op Interference_Risk_Type ni
has severity op Moderate_Sev ni
imdrf code dp "A0701"
risk name dp "Metallic artifact - MRI"
description dp "Metallic implant causing MRI image artifacts compromising diagnostics"

Near_Miss_Incident_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Near_Miss_Incident_Type

Instance used to flag an event that did not cause harm but could have done.
belongs to
Near Miss Incident c

Nipro Corporationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-013

Global manufacturer of renal and vascular products.
belongs to
Manufacturer c
has facts
authorization number dp "FR/2017/007788"
competent authority dp "Agence nationale de sécurité du médicament (ANSM)"
country dp "France"
eudamed s r n dp "SRN-FR-MED-0013"
email dp "regulatory@nipro.com"
name dp "Nipro Corporation"

OPTIGA Glucose Monitoring Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-021

Continuous glucose monitoring system for diabetic patients.
belongs to
Device c
has facts
has device type op Self_Test_Device_Type ni
has manufacturer op GE HealthCare Technologies ni
has risk class op Class_C ni
device name dp "OPTIGA Glucose Monitoring System"
intended purpose dp "Continuous glucose monitor for patients with diabetes"
is active dp "true"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "true"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)07300000001021"

Patient_Harm_Catni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Patient_Harm_Cat

Instance used to group risks by their area of impact.
belongs to
Patient Harm c

Persona Knee Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-009

Total knee arthroplasty implant system for joint replacement.
belongs to
Device c
has facts
has device type op Implantable_Type ni
has manufacturer op Zimmer Biomet Holdings ni
has risk class op Class_III ni
device name dp "Persona Knee System"
intended purpose dp "Total knee arthroplasty implant system"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)07612345001001"

Philips Medical Systemsni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-004

Healthcare technology company specializing in imaging and monitoring.
belongs to
Manufacturer c
has facts
authorization number dp "NL/2017/003456"
competent authority dp "Rijksinstituut voor Volksgezondheid en Milieu (RIVM)"
country dp "Netherlands"
eudamed s r n dp "SRN-NL-MED-0004"
email dp "regulatory@philips.com"
name dp "Philips Medical Systems"

Portico Transcatheter Heart Valveni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-003

Transcatheter aortic valve replacement system for TAVI procedures.
belongs to
Device c
has facts
has device type op Implantable_Type ni
has manufacturer op Abbott Medical Devices ni
has risk class op Class_III ni
device name dp "Portico Transcatheter Heart Valve"
intended purpose dp "Transcatheter aortic valve replacement (TAVI)"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)00800002222291"

Premature battery depletionni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-009

Unexpected battery failure prior to calculated end-of-life.
belongs to
Risk c
has facts
affected device type op Active_Implant_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Failure_Cat ni
has risk type op Malfunction_Rick_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0501"
risk name dp "Battery depletion - premature"
description dp "Battery end-of-life earlier than specified, risking therapy interruption"

Product_Quality_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Product_Quality_Type

Instance used to group risks by their area of impact.en
belongs to
Product Quality c

PROGENSA PCA3 Assayni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-019

Urine-based assay for prostate cancer molecular diagnosis.
belongs to
Device c
has facts
has device type op In_Vitro_Diagnostic_Device_Type ni
has manufacturer op Hologic Inc. ni
has risk class op Class_C ni
device name dp "PROGENSA PCA3 Assay"
intended purpose dp "Urine-based prostate cancer diagnosis assay"
is active dp "false"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)07000087001019"

Pump-induced hemolysisni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-004

Risk of red blood cell destruction by mechanical pump action.
belongs to
Risk c
has facts
affected device type op Active_Implant_Type ni
has probability op Low_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Injury_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "A0202"
risk name dp "Hemolysis - pump-induced"
description dp "Mechanical destruction of red blood cells by pump mechanism"

Radiation overdoseni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-011

Risk of unintended ionising radiation exposure to patients.
belongs to
Risk c
has facts
affected device type op Active_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Patient_Harm_Cat ni
has risk type op Radiaton_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0601"
risk name dp "Radiation overdose"
description dp "Unintended ionising radiation exposure exceeding therapeutic dose"

Radiaton_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Radiaton_Risk_Type

Instance used to specify the hazard.
belongs to
Radiation Risk c

Reagent contaminationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-017

Reagent contamination causing systematic diagnostic errors.
belongs to
Risk c
has facts
affected device type op In_Vitro_Diagnostic_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Product_Quality_Type ni
has risk type op Contamination_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "B0301"
risk name dp "Contamination - reagent"
description dp "Reagent lot contamination leading to systematic Diagnostic_Error_Cats"

Reagent cross-reactivityni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-016

Reagent cross-reactivity leading to incorrect test results.
belongs to
Risk c
has facts
affected device type op In_Vitro_Diagnostic_Device_Type ni
has probability op Medium_Probability_Type ni
has risk category op Diagnostic_Error_Cat ni
has risk type op Diagnostic_Risk_Type ni
has severity op Serious_Sev ni
imdrf code dp "B0201"
risk name dp "Cross-reactivity"
description dp "Reagent reacts with non-target analyte producing incorrect result"

Recall_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Recall_Type

Instance representing the removal of a device from the market.
belongs to
Recall c

Roche Diagnostics GmbHni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-005

Multinational healthcare company focused on pharmaceuticals and diagnostics.
belongs to
Manufacturer c
has facts
authorization number dp "DE/2017/007890"
competent authority dp "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"
country dp "Germany"
eudamed s r n dp "SRN-DE-MED-0005"
email dp "regulatory@roche.com"
name dp "Roche Diagnostics GmbH"

Safety_Alert_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Safety_Alert_Type

Value used to categorize notifications regarding critical safety updates to users.
belongs to
Safety Alert c

Self_Test_Device_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Self_Test_Device_Type

Device category used to define its use.
belongs to
Self Test Device c

Serious_Incident_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Serious_Incident_Type

Instance used to flag events resulting in death or serious problems.
belongs to
Serious Incident c

Serious_Sevni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Serious_Sev

Value used to show severity.
belongs to
Serious c

Siemens Healthineers AGni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-003

Leading provider of medical imaging and laboratory diagnostics.
belongs to
Manufacturer c
has facts
authorization number dp "DE/2017/009012"
competent authority dp "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)"
country dp "Germany"
eudamed s r n dp "SRN-DE-MED-0003"
email dp "regulatory@siemens-healthineers.com"
name dp "Siemens Healthineers AG"

Single_Use_Device_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Single_Use_Device_Type

Device category used to define its use.
belongs to
Single Use Device c

Software malfunctionni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#RSK-010

Critical software bug affecting therapy or dosing delivery.
belongs to
Risk c
has facts
affected device type op Active_Device_Type ni
has probability op Low_Probability_Type ni
has risk category op Device_Failure_Cat ni
has risk type op Software_Risk_Type ni
has severity op Critical_Sev ni
imdrf code dp "A0502"
risk name dp "Software malfunction"
description dp "Software bug causing incorrect dosing, alarming, or therapy delivery"

Software_Risk_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#Software_Risk_Type

Instance used to specify the hazard.
belongs to
Software Risk c

STELLAREX Drug-Coated Balloonni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-006

Drug-coated angioplasty balloon for peripheral artery treatment.
belongs to
Device c
has facts
has device type op Single_Use_Device_Type ni
has manufacturer op Philips Medical Systems ni
has risk class op Class_IIb ni
device name dp "STELLAREX Drug-Coated Balloon"
intended purpose dp "Peripheral artery drug-coated angioplasty balloon"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "false"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)08718998000001"

Stryker Corporationni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-007

Medical technology company focused on orthopaedics and spine surgery.
belongs to
Manufacturer c
has facts
authorization number dp "NL/2017/006789"
competent authority dp "Rijksinstituut voor Volksgezondheid en Milieu (RIVM)"
country dp "Netherlands"
eudamed s r n dp "SRN-NL-MED-0007"
email dp "regulatory@stryker.com"
name dp "Stryker Corporation"

SYNERGY Stent Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-004

Drug-eluting coronary stent system for cardiovascular intervention.
belongs to
Device c
has facts
has device type op Implantable_Active_Type ni
has manufacturer op Boston Scientific Corporation ni
has risk class op Class_IIb ni
device name dp "SYNERGY Stent System"
intended purpose dp "Drug-eluting coronary stent"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)08714729002817"

Tivoli II Cochlear Implantni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-023

Active cochlear implant system for sensorineural hearing loss.
belongs to
Device c
has facts
has device type op Active_Implant_Type ni
has manufacturer op Biotronik SE & Co. KG ni
has risk class op Class_III ni
device name dp "Tivoli II Cochlear Implant"
intended purpose dp "Active cochlear implant for sensorineural hearing loss"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04012099001023"

TRITON Total Hip Systemni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-010

Ceramic-on-ceramic total hip replacement system.
belongs to
Device c
has facts
has device type op Implantable_Type ni
has manufacturer op Stryker Corporation ni
has risk class op Class_III ni
device name dp "TRITON Total Hip System"
intended purpose dp "Ceramic-on-ceramic total hip replacement"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)09876543002002"

User_Notice_Typeni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#User_Notice_Type

Represents the specific notice sent to the user.
belongs to
User Notice c

ValveXpert Transcatheter Mitral Valveni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-025

Transcatheter mitral valve replacement system.
belongs to
Device c
has facts
has device type op Implantable_Type ni
has manufacturer op LivaNova PLC ni
has risk class op Class_III ni
device name dp "ValveXpert Transcatheter Mitral Valve"
intended purpose dp "Transcatheter mitral valve replacement system"
is active dp "false"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)05391520001025"

VIDAS HIV DUO Ultrani back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-018

Combined HIV antigen and antibody detection assay.
belongs to
Device c
has facts
has device type op In_Vitro_Diagnostic_Device_Type ni
has manufacturer op bioMérieux SA ni
has risk class op Class_D ni
device name dp "VIDAS HIV DUO Ultra"
intended purpose dp "Combined HIV Ag/Ab detection assay"
is active dp "false"^^boolean
is i v d dp "true"^^boolean
is implantable dp "false"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "IVDR"
udi_di dp "(01)03760027001018"

Viva Cardiac Resynchronization Defibrillatorni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#DEV-012

Cardiac resynchronization therapy device with defibrillation capacity.
belongs to
Device c
has facts
has device type op Active_Implant_Type ni
has manufacturer op Biotronik SE & Co. KG ni
has risk class op Class_III ni
device name dp "Viva Cardiac Resynchronization Defibrillator"
intended purpose dp "Cardiac resynchronization therapy with defibrillation"
is active dp "true"^^boolean
is i v d dp "false"^^boolean
is implantable dp "true"^^boolean
is reusable dp "false"^^boolean
regulatory framework dp "MDR"
udi_di dp "(01)04012099001012"

Zimmer Biomet Holdingsni back to ToC or Named Individual ToC

IRI: http://www.noel-garcia.org/ontologies/medical-devices#MAN-010

Global leader in musculoskeletal healthcare and joint replacement.
belongs to
Manufacturer c
has facts
authorization number dp "CH/2017/001122"
competent authority dp "Swissmedic"
country dp "Switzerland"
eudamed s r n dp "SRN-CH-MED-0010"
email dp "regulatory@zimmerbiomet.com"
name dp "Zimmer Biomet Holdings"

SWRL rules

Device risk Class Aback to ToC or SWRL ToC

Class A risk

Device c(?d) , has risk class op(?d,?Class_A) -> Class A c(?d)

Device risk Class Bback to ToC or SWRL ToC

Class B risk

Device c(?d) , has risk class op(?d,?Class_B) -> Class B c(?d)

Device risk Class Cback to ToC or SWRL ToC

Class C risk

Device c(?d) , has risk class op(?d,?Class_C) -> Class C c(?d)

Device risk Class Dback to ToC or SWRL ToC

Class D risk

Device c(?d) , has risk class op(?d,?Class_D) -> Class D c(?d)

Device risk Class Iback to ToC or SWRL ToC

Class I risk

Device c(?d) , has risk class op(?d,?Class_I) -> Class I c(?d)

Device risk Class IIaback to ToC or SWRL ToC

Class IIa risk

Device c(?d) , has risk class op(?d,?Class_IIa) -> Class I Ia c(?d)

Device risk Class IIbback to ToC or SWRL ToC

Class IIb risk

Device c(?d) , has risk class op(?d,?Class_IIb) -> Class I Ib c(?d)

Device risk Class IIIback to ToC or SWRL ToC

Class III risk

Device c(?d) , has risk class op(?d,?Class_III) -> Class I I I c(?d)

Device type Active Deviceback to ToC or SWRL ToC

Active Device

Device c(?d) , has device type op(?d,?Active_Device_Type) -> Active Device c(?d)

Device type Active Implantback to ToC or SWRL ToC

Active Implant

Device c(?d) , has device type op(?d,?Active_Implant_Type) -> Active Implant c(?d)

Device type Implantable Active Deviceback to ToC or SWRL ToC

Implantable Active Device

Device c(?d) , has device type op(?d,?Implantable_Active_Type) -> Implantable Active Device c(?d)

Device type Implantable Deviceback to ToC or SWRL ToC

Implantable Device

Device c(?d) , has device type op(?d,?Implantable_Type) -> Implantable Device c(?d)

Device type In Vitroback to ToC or SWRL ToC

In Vitro

Device c(?d) , has device type op(?d,?In_Vitro_Diagnostic_Device_Type) -> In Vitro Diagnostic Device c(?d)

Device type Self Testback to ToC or SWRL ToC

Self Test

Device c(?d) , has device type op(?d,?Self_Test_Device_Type) -> Self Test Device c(?d)

Device type Single Useback to ToC or SWRL ToC

Single Use

Device c(?d) , has device type op(?d,?Single_Use_Device_Type) -> Single Use Device c(?d)

In situback to ToC or SWRL ToC

CorrectiveAction - In Situ

Corrective Action c(?a) , has action type op(?a,?In_Situ_Correction_Type) -> In Situ Correction c(?a)

Near Miss Incidentback to ToC or SWRL ToC

Incident - Type

Incident c(?i) , has incident type op(?i,?Near_Miss_Incident_Type) -> Near Miss Incident c(?i)

Probability Highback to ToC or SWRL ToC

High Probability Level

Risk c(?r) , has probability op(?r,?High_Probability_Type) -> High c(?r)

Probability Lowback to ToC or SWRL ToC

Low Probability Level

Risk c(?r) , has probability op(?r,?Low_Probability_Type) -> Low c(?r)

Probability Mediumback to ToC or SWRL ToC

Medium Probability Level

Risk c(?r) , has probability op(?r,?Medium_Probability_Type) -> Medium c(?r)

Recallback to ToC or SWRL ToC

CorrectiveAction - Recall

Corrective Action c(?a) , has action type op(?a,?Recall_Type) -> Recall c(?a)

Risk cat Diagback to ToC or SWRL ToC

Diagnostic error

Risk c(?r) , has risk category op(?r,?Diagnostic_Error_Cat) -> Diagnostic Error c(?r)

Risk cat Failureback to ToC or SWRL ToC

Device Failure

Risk c(?r) , has risk category op(?r,?Device_Failure_Cat) -> Device Failure c(?r)

Risk cat Patientback to ToC or SWRL ToC

Patient Harm

Risk c(?r) , has risk category op(?r,?Patient_Harm_Cat) -> Patient Harm c(?r)

Risk cat Performanceback to ToC or SWRL ToC

Device Performance

Risk c(?r) , has risk category op(?r,?Device_Performance_Cat) -> Device Performance c(?r)

Risk cat prodback to ToC or SWRL ToC

Product quality

Risk c(?r) , has risk category op(?r,?Product_Quality_Type) -> Product Quality c(?r)

Risk cat Safetyback to ToC or SWRL ToC

Device Safety

Risk c(?r) , has risk category op(?r,?Device_Safety_Cat) -> Device Safety c(?r)

Risk type Contiaback to ToC or SWRL ToC

Contamination Risk

Risk c(?r) , has risk type op(?r,?Contamination_Risk_Type) -> Contamination Risk c(?r)

Risk type Cyberback to ToC or SWRL ToC

Cybersecurity Risk

Risk c(?r) , has risk type op(?r,?Cybersecurity_Risk_Type) -> Cybersecurity Risk c(?r)

Risk type Diagback to ToC or SWRL ToC

Diagnostic Risk

Risk c(?r) , has risk type op(?r,?Diagnostic_Risk_Type) -> Diagnostic Risk c(?r)

Risk type Infeback to ToC or SWRL ToC

Infection Risk

Risk c(?r) , has risk type op(?r,?Infection_Risk_Type) -> Infection Risk c(?r)

Risk type Injuryback to ToC or SWRL ToC

Injury Risk

Risk c(?r) , has risk type op(?r,?Injury_Risk_Type) -> Injury Risk c(?r)

Risk type Interfback to ToC or SWRL ToC

Interference Risk

Risk c(?r) , has risk type op(?r,?Interference_Risk_Type) -> Interference Risk c(?r)

Risk type Malfback to ToC or SWRL ToC

Malfunction Risk

Risk c(?r) , has risk type op(?r,?Malfunction_Rick_Type) -> Malfunction Risk c(?r)

Risk type Matback to ToC or SWRL ToC

Material Risk

Risk c(?r) , has risk type op(?r,?Material_Risk_Type) -> Material Risk c(?r)

Risk type Radback to ToC or SWRL ToC

Radiation Risk

Risk c(?r) , has risk type op(?r,?Radiaton_Risk_Type) -> Radiation Risk c(?r)

Risk type Softback to ToC or SWRL ToC

Software Risk

Risk c(?r) , has risk type op(?r,?Software_Risk_Type) -> Software Risk c(?r)

Safety Alertback to ToC or SWRL ToC

CorrectiveAction - Safety Alert

Corrective Action c(?a) , has action type op(?a,?Safety_Alert_Type) -> Safety Alert c(?a)

Serious Incidentback to ToC or SWRL ToC

Incident - Type

Incident c(?i) , has incident type op(?i,?Serious_Incident_Type) -> Serious c(?i)

Severity Criticalback to ToC or SWRL ToC

Critical Sev Level

Risk c(?r) , has severity op(?r,?Critical_Sev) -> Critical c(?r)

Severity Moderateback to ToC or SWRL ToC

Moderate Sev Level

Risk c(?r) , has severity op(?r,?Moderate_Sev) -> Moderate c(?r)

Severity Seriousback to ToC or SWRL ToC

Serious Sev Level

Risk c(?r) , has severity op(?r,?Serious_Sev) -> Serious c(?r)

User Noticeback to ToC or SWRL ToC

CorrectiveAction - User Notice

Corrective Action c(?a) , has action type op(?a,?User_Notice_Type) -> User Notice c(?a)

Legend back to ToC

c: Classes
op: Object Properties
dp: Data Properties
ni: Named Individuals

References back to ToC

Add your references here. It is recommended to have them as a list.

Acknowledgments back to ToC

The authors would like to thank Silvio Peroni for developing LODE, a Live OWL Documentation Environment, which is used for representing the Cross Referencing Section of this document and Daniel Garijo for developing Widoco, the program used to create the template used in this documentation.