In situ
type: Imp
is rule enabled: true
comment: CorrectiveAction - In Situ
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Corrective Action
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  argument2: In_Situ_Correction_Type
  property predicate: has action type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: In Situ Correction

Recall
type: Imp
is rule enabled: true
comment: CorrectiveAction - Recall
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Corrective Action
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  argument2: Recall_Type
  property predicate: has action type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Recall

Safety Alert
type: Imp
is rule enabled: true
comment: CorrectiveAction - Safety Alert
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Corrective Action
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  argument2: Safety_Alert_Type
  property predicate: has action type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Safety Alert

User Notice
type: Imp
is rule enabled: true
comment: CorrectiveAction - User Notice
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: Corrective Action
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  argument2: User_Notice_Type
  property predicate: has action type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#a
  class predicate: User Notice

Device type Active Device
type: Imp
is rule enabled: true
comment: Active Device
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Active_Device_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Active Device

Device type Active Implant
type: Imp
is rule enabled: true
comment: Active Implant
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Active_Implant_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Active Implant

Device risk Class A
type: Imp
is rule enabled: true
comment: Class A risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_A
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class A

Device risk Class B
type: Imp
is rule enabled: true
comment: Class B risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_B
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class B

Device risk Class C
type: Imp
is rule enabled: true
comment: Class C risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_C
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class C

Device risk Class D
type: Imp
is rule enabled: true
comment: Class D risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_D
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class D

Device risk Class I
type: Imp
is rule enabled: true
comment: Class I risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_I
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class I

Device risk Class III
type: Imp
is rule enabled: true
comment: Class III risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_III
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class I I I

Device risk Class IIa
type: Imp
is rule enabled: true
comment: Class IIa risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_IIa
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class I Ia

Device risk Class IIb
type: Imp
is rule enabled: true
comment: Class IIb risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Class_IIb
  property predicate: has risk class
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Class I Ib

Device type Implantable Active Device
type: Imp
is rule enabled: true
comment: Implantable Active Device
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Implantable_Active_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Implantable Active Device

Device type Implantable Device
type: Imp
is rule enabled: true
comment: Implantable Device
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Implantable_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Implantable Device

Device type In Vitro
type: Imp
is rule enabled: true
comment: In Vitro
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: In_Vitro_Diagnostic_Device_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: In Vitro Diagnostic Device

Device type Self Test
type: Imp
is rule enabled: true
comment: Self Test
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Self_Test_Device_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Self Test Device

Device type Single Use
type: Imp
is rule enabled: true
comment: Single Use
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Device
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  argument2: Single_Use_Device_Type
  property predicate: has device type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#d
  class predicate: Single Use Device

Near Miss Incident
type: Imp
is rule enabled: true
comment: Incident - Type
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  class predicate: Incident
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  argument2: Near_Miss_Incident_Type
  property predicate: has incident type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  class predicate: Near Miss Incident

Serious Incident
type: Imp
is rule enabled: true
comment: Incident - Type
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  class predicate: Incident
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  argument2: Serious_Incident_Type
  property predicate: has incident type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#i
  class predicate: Serious

Risk type Contia
type: Imp
is rule enabled: true
comment: Contamination Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Contamination_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Contamination Risk

Severity Critical
type: Imp
is rule enabled: true
comment: Critical Sev Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Critical_Sev
  property predicate: has severity
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Critical

Risk type Cyber
type: Imp
is rule enabled: true
comment: Cybersecurity Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Cybersecurity_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Cybersecurity Risk

Risk cat Failure
type: Imp
is rule enabled: true
comment: Device Failure
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Device_Failure_Cat
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Device Failure

Risk cat Performance
type: Imp
is rule enabled: true
comment: Device Performance
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Device_Performance_Cat
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Device Performance

Risk cat Safety
type: Imp
is rule enabled: true
comment: Device Safety
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Device_Safety_Cat
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Device Safety

Risk cat Diag
type: Imp
is rule enabled: true
comment: Diagnostic error
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Diagnostic_Error_Cat
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Diagnostic Error

Risk type Diag
type: Imp
is rule enabled: true
comment: Diagnostic Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Diagnostic_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Diagnostic Risk

Probability High
type: Imp
is rule enabled: true
comment: High Probability Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: High_Probability_Type
  property predicate: has probability
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: High

Risk type Infe
type: Imp
is rule enabled: true
comment: Infection Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Infection_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Infection Risk

Risk type Injury
type: Imp
is rule enabled: true
comment: Injury Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Injury_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Injury Risk

Risk type Interf
type: Imp
is rule enabled: true
comment: Interference Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Interference_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Interference Risk

Probability Low
type: Imp
is rule enabled: true
comment: Low Probability Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Low_Probability_Type
  property predicate: has probability
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Low

Risk type Malf
type: Imp
is rule enabled: true
comment: Malfunction Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Malfunction_Rick_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Malfunction Risk

Risk type Mat
type: Imp
is rule enabled: true
comment: Material Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Material_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Material Risk

Probability Medium
type: Imp
is rule enabled: true
comment: Medium Probability Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Medium_Probability_Type
  property predicate: has probability
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Medium

Severity Moderate
type: Imp
is rule enabled: true
comment: Moderate Sev Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Moderate_Sev
  property predicate: has severity
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Moderate

Risk cat Patient
type: Imp
is rule enabled: true
comment: Patient Harm
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Patient_Harm_Cat
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Patient Harm

Risk cat prod
type: Imp
is rule enabled: true
comment: Product quality
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Product_Quality_Type
  property predicate: has risk category
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Product Quality

Risk type Rad
type: Imp
is rule enabled: true
comment: Radiation Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Radiaton_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Radiation Risk

Severity Serious
type: Imp
is rule enabled: true
comment: Serious Sev Level
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Serious_Sev
  property predicate: has severity
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Serious

Risk type Soft
type: Imp
is rule enabled: true
comment: Software Risk
body: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Risk
body: IndividualPropertyAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  argument2: Software_Risk_Type
  property predicate: has risk type
head: ClassAtom
  argument1: http://www.noel-garcia.org/ontologies/medical-devices#r
  class predicate: Software Risk

description
type: AnnotationProperty
type: DatatypeProperty
comment: A textual description providing details about the incident or risk.
domain: Class
  union of: Corrective Action
  union of: Incident
  union of: Risk
range: string

PAC2 - Medical Devices and Incidents
type: Ontology
bibliographic citation: Noël García Pou (2026) - Medical Devices Ontology - UOC Project
created: 2026-04-04
creator: Noël García Pou
description: European high-risk medical devices.
issued: 2026-04-27
license: https://creativecommons.org/licenses/by/4.0/
publisher: Noël García Pou
preferred namespace prefix: mdo
version IRI: http://www.noel-garcia.org/ontologies/medical-devices/1.0.0
version info: 1.0.0
created with: chowlk.linkeddata.es
status: Project submission

Action Type
type: Class
comment: The type of corrective action taken in response to an incident.

Active Device
type: Class
comment: A medical device that relies on a source of energy other than the human body.
subclass of: Device Type

Active Implant
type: Class
comment: A surgically inserted medical device that relies on an external power source to function.
subclass of: Device Type

Active_Device_Type
type: NamedIndividual
type: Active Device
comment: Device category used to define its use.

Active_Implant_Type
type: NamedIndividual
type: Active Implant
comment: Device category used to define its use.

Class A
type: Class
comment: Risk Class A for in vitro diagnostic devices according to the IVDR framework.
subclass of: Device Risk Class

Class B
type: Class
comment: Risk Class B for in vitro diagnostic devices according to the IVDR framework.
subclass of: Device Risk Class

Class C
type: Class
comment: Risk Class C for in vitro diagnostic devices according to the IVDR framework.
subclass of: Device Risk Class

Class D
type: Class
comment: Risk Class D for in vitro diagnostic devices according to the IVDR framework.
subclass of: Device Risk Class

Class I
type: Class
comment: Risk Class I for medical devices according to the MDR framework.
subclass of: Device Risk Class

Class I I I
type: Class
comment: Risk Class III for medical devices according to the MDR framework.
subclass of: Device Risk Class

Class I Ia
type: Class
comment: Risk Class IIa for medical devices according to the MDR framework.
subclass of: Device Risk Class

Class I Ib
type: Class
comment: Risk Class IIb for medical devices according to the MDR framework.
subclass of: Device Risk Class

Class_A
type: NamedIndividual
type: Class A
comment: Standardized classification values for In Vitro Diagnostic (IVD) devices.

Class_B
type: NamedIndividual
type: Class B
comment: Standardized classification values for In Vitro Diagnostic (IVD) devices.

Class_C
type: NamedIndividual
type: Class C
comment: Standardized classification values for In Vitro Diagnostic (IVD) devices.

Class_D
type: NamedIndividual
type: Class D
comment: Standardized classification values for In Vitro Diagnostic (IVD) devices.

Class_I
type: NamedIndividual
type: Class I
comment: Standardized risk classification values for General Medical Devices.

Class_III
type: NamedIndividual
type: Class I I I
comment: Standardized risk classification values for General Medical Devices.

Class_IIa
type: NamedIndividual
type: Class I Ia
comment: Standardized risk classification values for General Medical Devices.

Class_IIb
type: NamedIndividual
type: Class I Ib
comment: Standardized risk classification values for General Medical Devices.

Contamination Risk
type: Class
comment: A risk associated with contamination of a device by biological, chemical, or other substances.
subclass of: Risk Type

Contamination_Risk_Type
type: NamedIndividual
type: Contamination Risk
comment: Instance used to specify the hazard.

Corrective Action
type: Class
comment: An action taken to manage a safety issue related to a medical device.
subclass of: Restriction
  cardinality: 1
  on property: has action type
subclass of: Restriction
  cardinality: 1
  on property: related to incident
subclass of: Restriction
  cardinality: 1
  on property: description
subclass of: Restriction
  cardinality: 1
  on property: action date
subclass of: Restriction
  cardinality: 1
  on property: countries affected
subclass of: Restriction
  cardinality: 1
  on property: devices affected
subclass of: Restriction
  cardinality: 1
  on property: eudamed f s c a ref
subclass of: Restriction
  cardinality: 1
  on property: scope
subclass of: Restriction
  cardinality: 1
  on property: status
subclass of: Restriction
  max cardinality: 1
  on property: closure date

Critical
type: Class
comment: A severity level indicating life-threatening or fatal consequences.
subclass of: Severity Level

Critical_Sev
type: NamedIndividual
type: Critical
comment: Value used to show severity.

Cybersecurity Risk
type: Class
comment: A risk related to unauthorized access, data breaches, or cyber attacks affecting a medical device.
subclass of: Risk Type

Cybersecurity_Risk_Type
type: NamedIndividual
type: Cybersecurity Risk
comment: Instance used to specify the hazard.

HeartMate 3 LVAD
type: NamedIndividual
device name: HeartMate 3 LVAD
has device type: Implantable_Active_Type
has manufacturer: Medtronic plc
has risk class: Class_III
intended purpose: Ventricular assist device for end-stage heart failure
is active: true
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)00380740009095
type: Device
comment: Ventricular assist device for end-stage heart failure treatment.

Micra AV Transcatheter Pacing System
type: NamedIndividual
device name: Micra AV Transcatheter Pacing System
has device type: Active_Implant_Type
has manufacturer: Medtronic plc
has risk class: Class_III
intended purpose: Leadless cardiac pacemaker for atrioventricular synchrony
is active: true
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)00380740009112
type: Device
comment: Leadless cardiac pacemaker designed for atrioventricular synchrony.

Portico Transcatheter Heart Valve
type: NamedIndividual
device name: Portico Transcatheter Heart Valve
has device type: Implantable_Type
has manufacturer: Abbott Medical Devices
has risk class: Class_III
intended purpose: Transcatheter aortic valve replacement (TAVI)
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)00800002222291
type: Device
comment: Transcatheter aortic valve replacement system for TAVI procedures.

SYNERGY Stent System
type: NamedIndividual
device name: SYNERGY Stent System
has device type: Implantable_Active_Type
has manufacturer: Boston Scientific Corporation
has risk class: Class_IIb
intended purpose: Drug-eluting coronary stent
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)08714729002817
type: Device
comment: Drug-eluting coronary stent system for cardiovascular intervention.

ACUITY X4 Quadripolar LV Lead
type: NamedIndividual
device name: ACUITY X4 Quadripolar LV Lead
has device type: Active_Implant_Type
has manufacturer: Boston Scientific Corporation
has risk class: Class_III
intended purpose: Cardiac resynchronization therapy lead
is active: true
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)08714729004873
type: Device
comment: Quadripolar LV lead for cardiac resynchronization therapy.

STELLAREX Drug-Coated Balloon
type: NamedIndividual
device name: STELLAREX Drug-Coated Balloon
has device type: Single_Use_Device_Type
has manufacturer: Philips Medical Systems
has risk class: Class_IIb
intended purpose: Peripheral artery drug-coated angioplasty balloon
is active: false
is i v d: false
is implantable: false
is reusable: false
regulatory framework: MDR
udi_di: (01)08718998000001
type: Device
comment: Drug-coated angioplasty balloon for peripheral artery treatment.

ACUSON Sequoia Ultrasound
type: NamedIndividual
device name: ACUSON Sequoia Ultrasound
has device type: Active_Device_Type
has manufacturer: Siemens Healthineers AG
has risk class: Class_IIa
intended purpose: Diagnostic ultrasound imaging system
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)04054839450001
type: Device
comment: High-performance diagnostic ultrasound imaging system.

MAGNETOM Vida MRI System
type: NamedIndividual
device name: MAGNETOM Vida MRI System
has device type: Active_Device_Type
has manufacturer: Siemens Healthineers AG
has risk class: Class_IIa
intended purpose: Magnetic resonance imaging system 3T
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)04054839460002
type: Device
comment: 3T magnetic resonance imaging system for advanced diagnostics.

Persona Knee System
type: NamedIndividual
device name: Persona Knee System
has device type: Implantable_Type
has manufacturer: Zimmer Biomet Holdings
has risk class: Class_III
intended purpose: Total knee arthroplasty implant system
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)07612345001001
type: Device
comment: Total knee arthroplasty implant system for joint replacement.

TRITON Total Hip System
type: NamedIndividual
device name: TRITON Total Hip System
has device type: Implantable_Type
has manufacturer: Stryker Corporation
has risk class: Class_III
intended purpose: Ceramic-on-ceramic total hip replacement
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)09876543002002
type: Device
comment: Ceramic-on-ceramic total hip replacement system.

Iluvien Intravitreal Implant
type: NamedIndividual
device name: Iluvien Intravitreal Implant
has device type: Active_Implant_Type
has manufacturer: LivaNova PLC
has risk class: Class_III
intended purpose: Sustained-release fluocinolone acetonide ocular implant
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)05391520001011
type: Device
comment: Sustained-release intravitreal implant for ocular therapy.

Viva Cardiac Resynchronization Defibrillator
type: NamedIndividual
device name: Viva Cardiac Resynchronization Defibrillator
has device type: Active_Implant_Type
has manufacturer: Biotronik SE & Co. KG
has risk class: Class_III
intended purpose: Cardiac resynchronization therapy with defibrillation
is active: true
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)04012099001012
type: Device
comment: Cardiac resynchronization therapy device with defibrillation capacity.

ATERA Mechanical Ventilator
type: NamedIndividual
device name: ATERA Mechanical Ventilator
has device type: Active_Device_Type
has manufacturer: Drägerwerk AG & Co. KGaA
has risk class: Class_IIb
intended purpose: ICU mechanical ventilator with pressure and volume modes
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)04046539001013
type: Device
comment: ICU mechanical ventilator with advanced ventilation modes.

Lumify Portable Ultrasound
type: NamedIndividual
device name: Lumify Portable Ultrasound
has device type: Active_Device_Type
has manufacturer: Philips Medical Systems
has risk class: Class_IIa
intended purpose: Handheld point-of-care ultrasound probe
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)08718998001014
type: Device
comment: Handheld point-of-care ultrasound diagnostic probe.

Hemodialysis Machine 5008S
type: NamedIndividual
device name: Hemodialysis Machine 5008S
has device type: Active_Device_Type
has manufacturer: Nipro Corporation
has risk class: Class_IIb
intended purpose: High-volume online hemodiafiltration machine
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)04547597001015
type: Device
comment: High-volume online hemodiafiltration machine for renal care.

cobas e 801 Immunoassay Analyzer
type: NamedIndividual
device name: cobas e 801 Immunoassay Analyzer
has device type: In_Vitro_Diagnostic_Device_Type
has manufacturer: Roche Diagnostics GmbH
has risk class: Class_C
intended purpose: Automated immunoassay analyzer for clinical laboratory
is active: true
is i v d: true
is implantable: false
is reusable: true
regulatory framework: IVDR
udi_di: (01)04015630001016
type: Device
comment: Automated immunoassay analyzer for clinical laboratory use.

cobas SARS-CoV-2 RT-PCR Test
type: NamedIndividual
device name: cobas SARS-CoV-2 RT-PCR Test
has device type: In_Vitro_Diagnostic_Device_Type
has manufacturer: Roche Diagnostics GmbH
has risk class: Class_C
intended purpose: Molecular diagnostic test for SARS-CoV-2 detection
is active: false
is i v d: true
is implantable: false
is reusable: false
regulatory framework: IVDR
udi_di: (01)04015630001017
type: Device
comment: Molecular diagnostic test kit for SARS-CoV-2 detection.

VIDAS HIV DUO Ultra
type: NamedIndividual
device name: VIDAS HIV DUO Ultra
has device type: In_Vitro_Diagnostic_Device_Type
has manufacturer: bioMérieux SA
has risk class: Class_D
intended purpose: Combined HIV Ag/Ab detection assay
is active: false
is i v d: true
is implantable: false
is reusable: false
regulatory framework: IVDR
udi_di: (01)03760027001018
type: Device
comment: Combined HIV antigen and antibody detection assay.

PROGENSA PCA3 Assay
type: NamedIndividual
device name: PROGENSA PCA3 Assay
has device type: In_Vitro_Diagnostic_Device_Type
has manufacturer: Hologic Inc.
has risk class: Class_C
intended purpose: Urine-based prostate cancer diagnosis assay
is active: false
is i v d: true
is implantable: false
is reusable: false
regulatory framework: IVDR
udi_di: (01)07000087001019
type: Device
comment: Urine-based assay for prostate cancer molecular diagnosis.

Harmony Prenatal Test
type: NamedIndividual
device name: Harmony Prenatal Test
has device type: In_Vitro_Diagnostic_Device_Type
has manufacturer: Abbott Medical Devices
has risk class: Class_D
intended purpose: Non-invasive prenatal testing (NIPT) for aneuploidies
is active: false
is i v d: true
is implantable: false
is reusable: false
regulatory framework: IVDR
udi_di: (01)00800002001020
type: Device
comment: Non-invasive prenatal test for detecting genetic aneuploidies.

OPTIGA Glucose Monitoring System
type: NamedIndividual
device name: OPTIGA Glucose Monitoring System
has device type: Self_Test_Device_Type
has manufacturer: GE HealthCare Technologies
has risk class: Class_C
intended purpose: Continuous glucose monitor for patients with diabetes
is active: true
is i v d: true
is implantable: false
is reusable: true
regulatory framework: IVDR
udi_di: (01)07300000001021
type: Device
comment: Continuous glucose monitoring system for diabetic patients.

BeneVision N1 Patient Monitor
type: NamedIndividual
device name: BeneVision N1 Patient Monitor
has device type: Active_Device_Type
has manufacturer: GE HealthCare Technologies
has risk class: Class_IIa
intended purpose: Portable patient monitor for vital signs
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)07300000001022
type: Device
comment: Portable patient monitor for real-time vital signs tracking.

Tivoli II Cochlear Implant
type: NamedIndividual
device name: Tivoli II Cochlear Implant
has device type: Active_Implant_Type
has manufacturer: Biotronik SE & Co. KG
has risk class: Class_III
intended purpose: Active cochlear implant for sensorineural hearing loss
is active: true
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)04012099001023
type: Device
comment: Active cochlear implant system for sensorineural hearing loss.

Infusion Pump Plum 360
type: NamedIndividual
device name: Infusion Pump Plum 360
has device type: Active_Device_Type
has manufacturer: Abbott Medical Devices
has risk class: Class_IIb
intended purpose: Large volume infusion pump with drug library
is active: true
is i v d: false
is implantable: false
is reusable: true
regulatory framework: MDR
udi_di: (01)00800002001024
type: Device
comment: Large volume infusion pump with integrated drug library.

ValveXpert Transcatheter Mitral Valve
type: NamedIndividual
device name: ValveXpert Transcatheter Mitral Valve
has device type: Implantable_Type
has manufacturer: LivaNova PLC
has risk class: Class_III
intended purpose: Transcatheter mitral valve replacement system
is active: false
is i v d: false
is implantable: true
is reusable: false
regulatory framework: MDR
udi_di: (01)05391520001025
type: Device
comment: Transcatheter mitral valve replacement system.

Device
type: Class
comment: A medical device used for diagnostic or therapeutic purposes
same as: http://dbpedia.org/resource/Medical_device
subclass of: Restriction
  on class: Device Type
  on property: has device type
  qualified cardinality: 1
subclass of: Restriction
  cardinality: 1
  on property: has manufacturer
subclass of: Restriction
  cardinality: 1
  on property: has risk class
subclass of: Restriction
  cardinality: 1
  on property: device name
subclass of: Restriction
  cardinality: 1
  on property: intended purpose
subclass of: Restriction
  cardinality: 1
  on property: is active
subclass of: Restriction
  cardinality: 1
  on property: is i v d
subclass of: Restriction
  cardinality: 1
  on property: is implantable
subclass of: Restriction
  cardinality: 1
  on property: is reusable
subclass of: Restriction
  cardinality: 1
  on property: regulatory framework
subclass of: Restriction
  cardinality: 1
  on property: udi_di

Device Failure
type: Class
comment: A risk category related to malfunction or failure of a medical device.
subclass of: Risk Category

Device Performance
type: Class
comment: A risk category related to issues affecting the performance of a medical device.
subclass of: Risk Category

Device Risk Class
type: Class
comment: A classification level indicating the risk associated with a medical device.

Device Safety
type: Class
comment: A risk category concerning the safety aspects of a medical device.
subclass of: Risk Category

Device Type
type: Class
comment: The type of the device

Device_Failure_Cat
type: NamedIndividual
type: Device Failure
comment: Instance used to group risks by their area of impact.

Device_Performance_Cat
type: NamedIndividual
type: Device Performance
comment: Instance used to group risks by their area of impact.

Device_Safety_Cat
type: NamedIndividual
type: Device Safety
comment: Instance used to group risks by their area of impact.

Diagnostic Error
type: Class
comment: A risk category involving incorrect diagnostic results produced by a device.
subclass of: Risk Category

Diagnostic Risk
type: Class
comment: A risk involving incorrect or unreliable diagnostic results produced by a device.
subclass of: Risk Type

Diagnostic_Error_Cat
type: NamedIndividual
type: Diagnostic Error
comment: Instance used to group risks by their area of impact.

Diagnostic_Risk_Type
type: NamedIndividual
type: Diagnostic Risk
comment: Instance used to specify the hazard.

FSCA-001 (Safety Alert)
type: NamedIndividual
description: 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.
action date: 2024-02-01
countries affected: EU-wide
devices affected: 850
eudamed f s c a ref: EU-FSCA-2024-000001
has action type: Safety_Alert_Type
related to incident: Incident INC-001 (Embolic stroke)
scope: All HeartMate 3 LVAD units implanted since 2020
status: Open
type: Corrective Action
comment: Safety alert regarding anticoagulation protocol updates.

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

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

FSCA-004 (Safety Alert)
type: NamedIndividual
description: Safety communication to implanting cardiologists regarding optimal fixation technique for ACUITY X4 lead. Enhanced fluoroscopy verification protocol at implantation.
action date: 2024-04-10
countries affected: EU-wide
devices affected: 2100
eudamed f s c a ref: EU-FSCA-2024-000004
has action type: Safety_Alert_Type
related to incident: Incident INC-005 (Lead dislodgement)
scope: All ACUITY X4 quadripolar LV leads
status: Open
type: Corrective Action
comment: Communication on optimal fixation techniques for cardiac leads.

FSCA-005 (In Situ Correction)
type: NamedIndividual
description: Enhanced surveillance programme: annual DEXA scan and serum particle monitoring for patients with affected tibial inserts. Patients contacted individually.
action date: 2024-05-20
closure date: 2024-09-30
countries affected: EU-wide + Switzerland
devices affected: 780
eudamed f s c a ref: EU-FSCA-2024-000005
has action type: In_Situ_Correction_Type
related to incident: Incident INC-007 (Tissue reaction)
scope: Persona Knee tibial inserts with lot numbers PN-2019-* to PN-2021-*
status: Closed
type: Corrective Action
comment: Enhanced surveillance programme for patients with joint implants.

FSCA-006 (Recall)
type: NamedIndividual
description: 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.
action date: 2024-05-30
countries affected: EU-wide
devices affected: 540
eudamed f s c a ref: EU-FSCA-2024-000006
has action type: Recall_Type
related to incident: Incident INC-008 (Cobalt toxicity)
scope: TRITON Total Hip ceramic-on-ceramic 28mm heads from lots TH-2020-* and TH-2021-*
status: Open
type: Corrective Action
comment: Urgent recall of hip implants due to metal ion release.

FSCA-007 (User Notice)
type: NamedIndividual
description: 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.
action date: 2024-05-25
closure date: 2024-07-31
countries affected: EU-wide + UK
devices affected: 4300
eudamed f s c a ref: EU-FSCA-2024-000007
has action type: User_Notice_Type
related to incident: Incident INC-009 (Inappropriate shock)
scope: All Viva CRT-D devices
status: Closed
type: Corrective Action
comment: Safety notice regarding updated MRI-conditional guidelines.

FSCA-008 (Recall)
type: NamedIndividual
description: 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.
action date: 2024-06-05
closure date: 2024-08-15
countries affected: EU-wide
devices affected: 180
eudamed f s c a ref: EU-FSCA-2024-000008
has action type: Recall_Type
related to incident: Incident INC-009 (Inappropriate shock)
scope: ATERA ventilators with software version 2.1.3
status: Closed
type: Corrective Action
comment: Mandatory software update to correct ventilator calibration.

FSCA-009 (User Notice)
type: NamedIndividual
description: Customer field notification regarding biotin interference in TSH assay. Updated sample preparation protocol and interference screening algorithm released via software update 4.1.2.
action date: 2024-06-20
closure date: 2024-09-30
countries affected: EU-wide
devices affected: 620
eudamed f s c a ref: EU-FSCA-2024-000009
has action type: User_Notice_Type
related to incident: Incident INC-011 (False positive TSH)
scope: All cobas e 801 immunoassay analysers
status: Closed
type: Corrective Action
comment: Field notification regarding interference screening in assays.

FSCA-010 (Recall)
type: NamedIndividual
description: 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.
action date: 2024-06-30
closure date: 2024-08-31
countries affected: EU-wide + Norway + Iceland
devices affected: 12500
eudamed f s c a ref: EU-FSCA-2024-000010
has action type: Recall_Type
related to incident: Incident INC-012 (False negative SARS-CoV-2)
scope: cobas SARS-CoV-2 RT-PCR reagent lot numbers CV-2024-0312 to CV-2024-0318
status: Closed
type: Corrective Action
comment: Immediate quarantine and replacement of diagnostic reagent lots.

FSCA-011 (In Situ Correction)
type: NamedIndividual
description: 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.
action date: 2024-08-01
countries affected: EU-wide
devices affected: 3200
eudamed f s c a ref: EU-FSCA-2024-000011
has action type: In_Situ_Correction_Type
related to incident: Incident INC-014 (Hyperglycaemic event)
scope: All OPTIGA CGM sensors from manufacturing site GE-SGP-2
status: Open
type: Corrective Action
comment: Mandatory firmware update to improve sensor compensation.

FSCA-012 (Recall)
type: NamedIndividual
description: 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.
action date: 2024-08-20
closure date: 2024-10-31
countries affected: EU-wide + UK + Norway
devices affected: 2870
eudamed f s c a ref: EU-FSCA-2024-000012
has action type: Recall_Type
related to incident: Incident INC-015 (Drug overdose)
scope: Plum 360 infusion pumps with drug library version 4.2.1
status: Closed
type: Corrective Action
comment: Urgent recall and software update for infusion pump drug library.

FSCA-013 (Safety Alert)
type: NamedIndividual
description: 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.
action date: 2024-09-10
countries affected: EU-wide
devices affected: 420
eudamed f s c a ref: EU-FSCA-2024-000013
has action type: Safety_Alert_Type
related to incident: Incident INC-016 (Haemolytic anaemia)
scope: All HeartMate 3 LVAD units with outflow graft lot OG-2022-*
status: Open
type: Corrective Action
comment: Communication regarding outflow graft routing techniques.

FSCA-014 (User Notice)
type: NamedIndividual
description: 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.
action date: 2024-09-25
closure date: 2024-12-31
countries affected: EU-wide
devices affected: 1100
eudamed f s c a ref: EU-FSCA-2024-000014
has action type: User_Notice_Type
related to incident: Incident INC-017 (Endophthalmitis)
scope: All Iluvien intravitreal implants
status: Closed
type: Corrective Action
comment: Updated clinical protocol for infection prophylaxis.

FSCA-015 (In Situ Correction)
type: NamedIndividual
description: 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.
action date: 2024-10-01
countries affected: EU-wide
devices affected: 890
eudamed f s c a ref: EU-FSCA-2024-000015
has action type: In_Situ_Correction_Type
related to incident: Incident INC-018 (Cybersecurity vulnerability)
scope: All 5008S hemodialysis machines with network connectivity module v2.x
status: Open
type: Corrective Action
comment: Deployment of security patch to disable unauthorized access.

High
type: Class
comment: A probability level indicating a high likelihood of occurrence.
subclass of: Probability Level

High_Probability_Type
type: NamedIndividual
type: High
comment: Value used to show likelihood.

Incident INC-001 (Embolic stroke)
type: NamedIndividual
description: Patient implanted with HeartMate 3 LVAD developed ischemic stroke 6 months post-implant. Device thrombus confirmed by echocardiography.
corrective action taken: true
country reported: Germany
detection date: 2024-01-10
eudamed incident ref: EU-INC-2024-000001
event date: 2024-01-08
has incident type: Serious_Incident_Type
has risk: Device thrombosis
involves device: HeartMate 3 LVAD
outcome: Serious_Sev patient injury - embolic stroke
patient age: 58
patient sex: Male
report date: 2024-01-15
reported by: Medtronic plc
type: Incident
comment: Serious injury involving embolic stroke and device thrombus.

Incident INC-002 (Battery depletion)
type: NamedIndividual
description: Micra AV pacemaker reached elective replacement indicator 14 months earlier than expected longevity specification.
corrective action taken: true
country reported: France
detection date: 2024-02-01
eudamed incident ref: EU-INC-2024-000002
event date: 2024-01-29
has incident type: Serious_Incident_Type
has risk: Premature battery depletion
involves device: Micra AV Transcatheter Pacing System
outcome: Device malfunction - premature battery depletion
patient age: 72
patient sex: Female
report date: 2024-02-03
reported by: Medtronic plc
type: Incident
comment: Malfunction report regarding premature battery depletion.

Incident INC-003 (Valve migration)
type: NamedIndividual
description: Portico valve showed paravalvular leak grade III due to partial migration 2 weeks post-TAVI procedure.
corrective action taken: true
country reported: Italy
detection date: 2024-02-18
eudamed incident ref: EU-INC-2024-000003
event date: 2024-02-15
has incident type: Serious_Incident_Type
has risk: Implant migration
involves device: Portico Transcatheter Heart Valve
outcome: Surgical intervention required - valve re-anchoring
patient age: 67
patient sex: Male
report date: 2024-02-20
reported by: Abbott Medical Devices
type: Incident
comment: Surgical intervention required due to valve migration.

Incident INC-004 (Stent fracture)
type: NamedIndividual
description: SYNERGY stent fracture detected on angiography 18 months post-implant causing in-stent restenosis.
corrective action taken: false
country reported: Spain
detection date: 2024-03-03
eudamed incident ref: EU-INC-2024-000004
event date: 2024-02-28
has incident type: Serious_Incident_Type
has risk: Mechanical failure
involves device: SYNERGY Stent System
outcome: Device malfunction - stent fracture
patient age: 55
patient sex: Female
report date: 2024-03-05
reported by: Boston Scientific Corporation
type: Incident
comment: Detection of stent fracture causing in-stent restenosis.

Incident INC-005 (Lead dislodgement)
type: NamedIndividual
description: ACUITY X4 lead dislodgement to right ventricle requiring fluoroscopy-guided repositioning.
corrective action taken: true
country reported: Netherlands
detection date: 2024-03-16
eudamed incident ref: EU-INC-2024-000005
event date: 2024-03-12
has incident type: Serious_Incident_Type
has risk: Lead dislodgement
involves device: ACUITY X4 Quadripolar LV Lead
outcome: Surgical intervention required - lead extraction
patient age: 63
patient sex: Male
report date: 2024-03-18
reported by: Boston Scientific Corporation
type: Incident
comment: Incident involving lead dislodgement requiring repositioning.

Incident INC-006 (System failure)
type: NamedIndividual
description: ACUSON Sequoia ultrasound system froze mid-examination. Emergency shutdown required; patient examination incomplete.
corrective action taken: false
country reported: Belgium
detection date: 2024-04-01
eudamed incident ref: EU-INC-2024-000006
event date: 2024-04-01
has incident type: Serious_Incident_Type
has risk: Electrical failure
involves device: ACUSON Sequoia Ultrasound
outcome: Device malfunction - complete system failure
patient sex: N/A
report date: 2024-04-02
reported by: Siemens Healthineers AG
type: Incident
comment: Complete system failure during patient ultrasound examination.

Incident INC-007 (Tissue reaction)
type: NamedIndividual
description: Persona knee tibial insert showing accelerated polyethylene wear with metallosis confirmed at 3-year revision surgery.
corrective action taken: true
country reported: Sweden
detection date: 2024-04-10
eudamed incident ref: EU-INC-2024-000007
event date: 2024-03-01
has incident type: Serious_Incident_Type
has risk: Joint wear debris
involves device: Persona Knee System
outcome: Patient_Harm_Cat - adverse tissue reaction
patient age: 70
patient sex: Male
report date: 2024-04-14
reported by: Zimmer Biomet Holdings
type: Incident
comment: Adverse tissue reaction caused by accelerated component wear.

Incident INC-008 (Cobalt toxicity)
type: NamedIndividual
description: TRITON hip patient presented with elevated serum cobalt (18 ppb). Adverse local tissue reaction (ALTR) confirmed by MRI.
corrective action taken: true
country reported: Denmark
detection date: 2024-04-25
eudamed incident ref: EU-INC-2024-000008
event date: 2024-04-20
has incident type: Serious_Incident_Type
has risk: Metallic corrosion
involves device: TRITON Total Hip System
outcome: Patient_Harm_Cat - cobalt toxicity
patient age: 65
patient sex: Female
report date: 2024-04-28
reported by: Stryker Corporation
type: Incident
comment: Report of cobalt toxicity and local tissue reaction.

Incident INC-009 (Inappropriate shock)
type: NamedIndividual
description: Viva CRT-D delivered inappropriate ICD therapy during MRI scan despite MRI-conditional programming. Patient experienced pain and syncope.
corrective action taken: true
country reported: Poland
detection date: 2024-05-04
eudamed incident ref: EU-INC-2024-000009
event date: 2024-05-03
has incident type: Serious_Incident_Type
has risk: Electromagnetic interference
involves device: Viva Cardiac Resynchronization Defibrillator
outcome: Inappropriate shock delivery
patient age: 68
patient sex: Male
report date: 2024-05-06
reported by: Biotronik SE & Co. KG
type: Incident
comment: Inappropriate ICD shock delivery during MRI procedure.

Incident INC-009 (Inappropriate shock)
type: NamedIndividual
description: ATERA ventilator software version 2.1.3 delivered FiO2 6% lower than set value for patients in ARDS protocol. 3 patients affected.
corrective action taken: true
country reported: Germany
detection date: 2024-05-19
eudamed incident ref: EU-INC-2024-000010
event date: 2024-05-19
has incident type: Serious_Incident_Type
has risk: Software malfunction
involves device: ATERA Mechanical Ventilator
outcome: Device malfunction - incorrect FiO2 delivery
patient sex: N/A
report date: 2024-05-20
reported by: Drägerwerk AG & Co. KGaA
type: Incident
comment: Ventilator software error causing incorrect FiO2 delivery.

Incident INC-011 (False positive TSH)
type: NamedIndividual
description: cobas e 801 thyroid-stimulating hormone (TSH) assay reported false positive results (>10 mIU/L) in 12 euthyroid patients due to biotin interference.
corrective action taken: true
country reported: France
detection date: 2024-06-01
eudamed incident ref: EU-INC-2024-000011
event date: 2024-05-28
has incident type: Serious_Incident_Type
has risk: False positive diagnostic
involves device: cobas e 801 Immunoassay Analyzer
outcome: Diagnostic_Error_Cat - false positive TSH results
patient sex: N/A
report date: 2024-06-03
reported by: Roche Diagnostics GmbH
type: Incident
comment: False positive results in TSH assay due to interference.

Incident INC-012 (False negative SARS-CoV-2)
type: NamedIndividual
description: cobas SARS-CoV-2 assay failed to detect Omicron BA.2.86 subvariant in 7 samples confirmed positive by sequencing. Lot-specific issue.
corrective action taken: true
country reported: Spain
detection date: 2024-06-13
eudamed incident ref: EU-INC-2024-000012
event date: 2024-06-10
has incident type: Serious_Incident_Type
has risk: False negative diagnostic
involves device: cobas SARS-CoV-2 RT-PCR Test
outcome: Diagnostic_Error_Cat - false negative SARS-CoV-2
patient sex: N/A
report date: 2024-06-15
reported by: Roche Diagnostics GmbH
type: Incident
comment: False negative results failing to detect SARS-CoV-2 subvariant.

Incident INC-013 (False negative HIV)
type: NamedIndividual
description: VIDAS HIV DUO Ultra failed to detect HIV-1 group O infection in seroconversion panel. Patient missed early treatment window.
corrective action taken: false
country reported: Germany
detection date: 2024-06-29
eudamed incident ref: EU-INC-2024-000013
event date: 2024-06-25
has incident type: Serious_Incident_Type
has risk: False negative diagnostic
involves device: VIDAS HIV DUO Ultra
outcome: Diagnostic_Error_Cat - false negative HIV
patient sex: N/A
report date: 2024-07-01
reported by: bioMérieux SA
type: Incident
comment: Missed detection of HIV-1 group O during seroconversion.

Incident INC-014 (Hyperglycaemic event)
type: NamedIndividual
description: OPTIGA CGM sensor reported glucose 3.8 mmol/L while laboratory reference showed 14.2 mmol/L. Patient delayed insulin administration.
corrective action taken: true
country reported: Netherlands
detection date: 2024-07-15
eudamed incident ref: EU-INC-2024-000014
event date: 2024-07-10
has incident type: Serious_Incident_Type
has risk: False positive diagnostic
involves device: OPTIGA Glucose Monitoring System
outcome: Patient_Harm_Cat - hyperglycaemic event
patient age: 45
patient sex: Female
report date: 2024-07-18
reported by: GE HealthCare Technologies
type: Incident
comment: Hyperglycaemic event caused by incorrect CGM glucose reading.

Incident INC-015 (Drug overdose)
type: NamedIndividual
description: Plum 360 infusion pump delivered 10x heparin dose due to software decimal point error in drug library version 4.2.1.
corrective action taken: true
country reported: Italy
detection date: 2024-08-04
eudamed incident ref: EU-INC-2024-000015
event date: 2024-08-04
has incident type: Serious_Incident_Type
has risk: Software malfunction
involves device: Infusion Pump Plum 360
outcome: Patient_Harm_Cat - drug overdose
patient age: 81
patient sex: Female
report date: 2024-08-05
reported by: Abbott Medical Devices
type: Incident
comment: Critical drug overdose due to software decimal point error.

Incident INC-016 (Haemolytic anaemia)
type: NamedIndividual
description: HeartMate 3 patient developed severe haemolysis (LDH >2000 U/L) associated with outflow graft kinking confirmed by CT.
corrective action taken: true
country reported: United Kingdom
detection date: 2024-08-18
eudamed incident ref: EU-INC-2024-000016
event date: 2024-08-15
has incident type: Serious_Incident_Type
has risk: Pump-induced hemolysis
involves device: HeartMate 3 LVAD
outcome: Patient_Harm_Cat - haemolytic anaemia
patient age: 52
patient sex: Male
report date: 2024-08-20
reported by: Medtronic plc
type: Incident
comment: Severe haemolysis associated with device graft kinking.

Incident INC-017 (Endophthalmitis)
type: NamedIndividual
description: Iluvien implant required surgical removal due to device-related endophthalmitis confirmed by vitreous culture.
corrective action taken: true
country reported: France
detection date: 2024-08-30
eudamed incident ref: EU-INC-2024-000017
event date: 2024-08-25
has incident type: Serious_Incident_Type
has risk: Device-related infection
involves device: Iluvien Intravitreal Implant
outcome: Surgical intervention - implant removal
patient age: 54
patient sex: Female
report date: 2024-09-02
reported by: LivaNova PLC
type: Incident
comment: Device-related endophthalmitis requiring implant removal.

Incident INC-018 (Cybersecurity vulnerability)
type: NamedIndividual
description: 5008S hemodialysis machine web interface exposed to hospital internal network. Unauthorised session accessed alarm configuration.
corrective action taken: true
country reported: Germany
detection date: 2024-09-14
eudamed incident ref: EU-INC-2024-000018
event date: 2024-09-12
has incident type: Serious_Incident_Type
has risk: Cybersecurity vulnerability
involves device: Hemodialysis Machine 5008S
outcome: Cybersecurity incident - unauthorised access
patient sex: N/A
report date: 2024-09-15
reported by: Nipro Corporation
type: Incident
comment: Cybersecurity vulnerability exposing device network interface.

Incident INC-019 (Activation failure)
type: NamedIndividual
description: Tivoli II cochlear implant failed to respond to initial activation programming. Sound processor replacement resolved the issue.
corrective action taken: false
country reported: Sweden
detection date: 2024-09-30
eudamed incident ref: EU-INC-2024-000019
event date: 2024-09-28
has incident type: Near_Miss_Incident_Type
has risk: Electrical failure
involves device: Tivoli II Cochlear Implant
outcome: Near-miss - device not activated post-surgery
patient age: 71
patient sex: Male
report date: 2024-10-01
reported by: Biotronik SE & Co. KG
type: Incident
comment: Near-miss incident involving cochlear implant activation failure.

Incident INC-020 (SAR heating injury)
type: NamedIndividual
description: MAGNETOM Vida MRI caused localised skin burn (1st degree) at anterior electrode lead in patient with DBS system not declared prior to scan.
corrective action taken: false
country reported: Belgium
detection date: 2024-10-12
eudamed incident ref: EU-INC-2024-000020
event date: 2024-10-10
has incident type: Serious_Incident_Type
has risk: Radiation overdose
involves device: MAGNETOM Vida MRI System
outcome: Patient_Harm_Cat - SAR heating injury
patient age: 38
patient sex: Female
report date: 2024-10-14
reported by: Siemens Healthineers AG
type: Incident
comment: Localised skin burn during MRI scan due to SAR heating.

Implantable Active Device
type: Class
comment: An active device intended to be completely or partially introduced into the body.
subclass of: Active Device
subclass of: Implantable Device

Implantable Device
type: Class
comment: A device intended to be placed inside the human body.
subclass of: Device Type

Implantable_Active_Type
type: NamedIndividual
type: Implantable Active Device
comment: Device category used to define its use.

Implantable_Type
type: NamedIndividual
type: Implantable Device
comment: Device category used to define its use.

In Situ Correction
type: Class
comment: A corrective action performed directly on the device at its location without removing it.
subclass of: Action Type

In Vitro Diagnostic Device
type: Class
comment: A device used to perform tests on samples outside the human body
subclass of: Device Type

In_Situ_Correction_Type
type: NamedIndividual
type: In Situ Correction
comment: Represents the specific action of performing repairs or adjustments at the device's location.

In_Vitro_Diagnostic_Device_Type
type: NamedIndividual
type: In Vitro Diagnostic Device
comment: Device category used to define its use.

Incident
type: Class
comment: An event related to a medical device that may cause or has caused harm.
subclass of: Restriction
  cardinality: 1
  on property: has incident type
subclass of: Restriction
  cardinality: 1
  on property: has risk
subclass of: Restriction
  cardinality: 1
  on property: involves device
subclass of: Restriction
  cardinality: 1
  on property: reported by
subclass of: Restriction
  cardinality: 1
  on property: description
subclass of: Restriction
  cardinality: 1
  on property: corrective action taken
subclass of: Restriction
  cardinality: 1
  on property: country reported
subclass of: Restriction
  cardinality: 1
  on property: detection date
subclass of: Restriction
  cardinality: 1
  on property: eudamed incident ref
subclass of: Restriction
  cardinality: 1
  on property: event date
subclass of: Restriction
  cardinality: 1
  on property: outcome
subclass of: Restriction
  cardinality: 1
  on property: report date
subclass of: Restriction
  max cardinality: 1
  on property: patient age
subclass of: Restriction
  max cardinality: 1
  on property: patient sex

Incident Type
type: Class
comment: The classification of the reported incident.

Infection Risk
type: Class
comment: A risk related to the potential transmission of infections through the use of a medical device.
subclass of: Risk Type

Infection_Risk_Type
type: NamedIndividual
type: Infection Risk
comment: Instance used to specify the hazard.

Injury Risk
type: Class
comment: A risk involving physical harm or injury to a patient or user caused by a device.
subclass of: Risk Type

Injury_Risk_Type
type: NamedIndividual
type: Injury Risk
comment: Instance used to specify the hazard.

Interference Risk
type: Class
comment: A risk caused by flaws in the interaction (physical, cognitive, or logical) between the person and the device.
subclass of: Risk Type

Interference_Risk_Type
type: NamedIndividual
type: Interference Risk
comment: Instance used to specify the hazard.

Low
type: Class
comment: A probability level indicating a low likelihood of occurrence.
subclass of: Probability Level

Low_Probability_Type
type: NamedIndividual
type: Low
comment: Value used to show likelihood.

Medtronic plc
type: NamedIndividual
authorization number: IE/2017/001234
competent authority: Health Products Regulatory Authority (HPRA)
country: Ireland
eudamed s r n: SRN-IE-MED-0001
type: Manufacturer
comment: Global medical technology company based in Ireland.
name: Medtronic plc

Abbott Medical Devices
type: NamedIndividual
authorization number: DE/2017/005678
competent authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
country: Germany
eudamed s r n: SRN-DE-MED-0002
type: Manufacturer
comment: Major manufacturer of cardiovascular and diabetes care devices.
name: Abbott Medical Devices

Siemens Healthineers AG
type: NamedIndividual
authorization number: DE/2017/009012
competent authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
country: Germany
eudamed s r n: SRN-DE-MED-0003
type: Manufacturer
comment: Leading provider of medical imaging and laboratory diagnostics.
name: Siemens Healthineers AG

Philips Medical Systems
type: NamedIndividual
authorization number: NL/2017/003456
competent authority: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
country: Netherlands
eudamed s r n: SRN-NL-MED-0004
type: Manufacturer
comment: Healthcare technology company specializing in imaging and monitoring.
name: Philips Medical Systems

Roche Diagnostics GmbH
type: NamedIndividual
authorization number: DE/2017/007890
competent authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
country: Germany
eudamed s r n: SRN-DE-MED-0005
type: Manufacturer
comment: Multinational healthcare company focused on pharmaceuticals and diagnostics.
name: Roche Diagnostics GmbH

Boston Scientific Corporation
type: NamedIndividual
authorization number: IE/2017/002345
competent authority: Health Products Regulatory Authority (HPRA)
country: Ireland
eudamed s r n: SRN-IE-MED-0006
type: Manufacturer
comment: Manufacturer of medical devices used in interventional specialties.
name: Boston Scientific Corporation

Stryker Corporation
type: NamedIndividual
authorization number: NL/2017/006789
competent authority: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
country: Netherlands
eudamed s r n: SRN-NL-MED-0007
type: Manufacturer
comment: Medical technology company focused on orthopaedics and spine surgery.
name: Stryker Corporation

Biotronik SE & Co. KG
type: NamedIndividual
authorization number: DE/2017/004567
competent authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
country: Germany
eudamed s r n: SRN-DE-MED-0008
type: Manufacturer
comment: Specialist in cardio- and endovascular medical technology.
name: Biotronik SE & Co. KG

GE HealthCare Technologies
type: NamedIndividual
authorization number: SE/2017/008901
competent authority: Läkemedelsverket (MPA)
country: Sweden
eudamed s r n: SRN-SE-MED-0009
type: Manufacturer
comment: Provider of medical imaging, monitoring, and digital solutions.
name: GE HealthCare Technologies

Zimmer Biomet Holdings
type: NamedIndividual
authorization number: CH/2017/001122
competent authority: Swissmedic
country: Switzerland
eudamed s r n: SRN-CH-MED-0010
type: Manufacturer
comment: Global leader in musculoskeletal healthcare and joint replacement.
name: Zimmer Biomet Holdings

LivaNova PLC
type: NamedIndividual
authorization number: UK/2017/003344
competent authority: Medicines and Healthcare products Regulatory Agency (MHRA)
country: United Kingdom
eudamed s r n: SRN-UK-MED-0011
type: Manufacturer
comment: Medical device company focused on cardiac surgery and neuromodulation.
name: LivaNova PLC

Drägerwerk AG & Co. KGaA
type: NamedIndividual
authorization number: DE/2017/005566
competent authority: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
country: Germany
eudamed s r n: SRN-DE-MED-0012
type: Manufacturer
comment: International leader in medical and safety technology.
name: Drägerwerk AG & Co. KGaA

Nipro Corporation
type: NamedIndividual
authorization number: FR/2017/007788
competent authority: Agence nationale de sécurité du médicament (ANSM)
country: France
eudamed s r n: SRN-FR-MED-0013
type: Manufacturer
comment: Global manufacturer of renal and vascular products.
name: Nipro Corporation

Hologic Inc.
type: NamedIndividual
authorization number: BE/2017/009900
competent authority: Agence fédérale des médicaments et des produits de santé (AFMPS)
country: Belgium
eudamed s r n: SRN-BE-MED-0014
type: Manufacturer
comment: Medical technology company primarily focused on women's health.
name: Hologic Inc.

bioMérieux SA
type: NamedIndividual
authorization number: FR/2017/002211
competent authority: Agence nationale de sécurité du médicament (ANSM)
country: France
eudamed s r n: SRN-FR-MED-0015
type: Manufacturer
comment: World leader in the field of in vitro diagnostics.
name: bioMérieux SA

Malfunction Risk
type: Class
comment: A risk related to the failure or malfunction of a medical device.
subclass of: Risk Type

Malfunction_Rick_Type
type: NamedIndividual
type: Malfunction Risk
comment: Instance used to specify the hazard.

Manufacturer
type: Class
comment: An organization responsible for producing medical devices and registering them in EUDAMED.
same as: http://dbpedia.org/resource/Manufacturer
subclass of: Restriction
  cardinality: 1
  on property: authorization number
subclass of: Restriction
  cardinality: 1
  on property: competent authority
subclass of: Restriction
  cardinality: 1
  on property: country
subclass of: Restriction
  cardinality: 1
  on property: eudamed s r n
subclass of: Restriction
  cardinality: 1
  on property: email
subclass of: Restriction
  cardinality: 1
  on property: name

Material Risk
type: Class
comment: A risk associated with the materials used in a device.
subclass of: Risk Type

Material_Risk_Type
type: NamedIndividual
type: Material Risk
comment: Instance used to specify the hazard.

Medium
type: Class
comment: A probability level indicating a moderate likelihood of occurrence.
subclass of: Probability Level

Medium_Probability_Type
type: NamedIndividual
type: Medium
comment: Value used to show likelihood.

Moderate
type: Class
comment: A severity level indicating moderate health impact requiring intervention.
subclass of: Severity Level

Moderate_Sev
type: NamedIndividual
type: Moderate
comment: Value used to show severity.

Near Miss Incident
type: Class
comment: A Near Miss incident involving a medical device.
subclass of: Incident Type
disjoint with: Serious Incident

Near_Miss_Incident_Type
type: NamedIndividual
type: Near Miss Incident
comment: Instance used to flag an event that did not cause harm but could have done.

Patient Harm
type: Class
comment: A risk category involving injury or harm caused to a patient.
subclass of: Risk Category

Patient_Harm_Cat
type: NamedIndividual
type: Patient Harm
comment: Instance used to group risks by their area of impact.

Probability Level
type: Class
comment: The likelihood of a risk occurring.

Product Quality
type: Class
comment: A risk category related to defects or quality issues in a medical device.
subclass of: Risk Category

Product_Quality_Type
type: NamedIndividual
type: Product Quality
comment: Instance used to group risks by their area of impact.en

Electrical failure
type: NamedIndividual
description: Complete loss of electrical function leading to device shutdown
affected device type: Active_Device_Type
has probability: Low_Probability_Type
has risk category: Device_Failure_Cat
has risk type: Malfunction_Rick_Type
has severity: Critical_Sev
imdrf code: A0101
risk name: Device_Failure_Cat - electrical
type: Risk
comment: Risk of complete electrical shutdown of the device.

Mechanical failure
type: NamedIndividual
description: Structural failure of mechanical components under physiological load
affected device type: Implantable_Type
has probability: Medium_Probability_Type
has risk category: Device_Failure_Cat
has risk type: Malfunction_Rick_Type
has severity: Critical_Sev
imdrf code: A0102
risk name: Device_Failure_Cat - mechanical
type: Risk
comment: Risk of structural mechanical failure under physiological load.

Device thrombosis
type: NamedIndividual
description: Thrombus formation on device surface causing embolic events
affected device type: Implantable_Active_Type
has probability: Low_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Injury_Risk_Type
has severity: Critical_Sev
imdrf code: A0201
risk name: Thrombosis - device-related
type: Risk
comment: Potential for thrombus formation on blood-contacting surfaces.

Pump-induced hemolysis
type: NamedIndividual
description: Mechanical destruction of red blood cells by pump mechanism
affected device type: Active_Implant_Type
has probability: Low_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Injury_Risk_Type
has severity: Serious_Sev
imdrf code: A0202
risk name: Hemolysis - pump-induced
type: Risk
comment: Risk of red blood cell destruction by mechanical pump action.

Implant migration
type: NamedIndividual
description: Unintended displacement of implant from intended anatomical position
affected device type: Implantable_Type
has probability: Low_Probability_Type
has risk category: Device_Performance_Cat
has risk type: Malfunction_Rick_Type
has severity: Serious_Sev
imdrf code: A0301
risk name: Device migration - implant
type: Risk
comment: Unintended migration of an implant from its original site.

Lead dislodgement
type: NamedIndividual
description: Cardiac lead displacement requiring repositioning or replacement
affected device type: Active_Implant_Type
has probability: Medium_Probability_Type
has risk category: Device_Performance_Cat
has risk type: Malfunction_Rick_Type
has severity: Serious_Sev
imdrf code: A0302
risk name: Lead dislodgement
type: Risk
comment: Potential for cardiac lead displacement post-implantation.

Device-related infection
type: NamedIndividual
description: Device-related infection at implantation site or systemic sepsis
affected device type: Implantable_Type
has probability: Medium_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Infection_Risk_Type
has severity: Serious_Sev
imdrf code: A0401
risk name: Infection - device-related
type: Risk
comment: Risk of infection or sepsis related to the medical device.

Biofilm formation
type: NamedIndividual
description: Bacterial biofilm accumulation on implant surface resistant to antibiotics
affected device type: Implantable_Type
has probability: High_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Infection_Risk_Type
has severity: Moderate_Sev
imdrf code: A0402
risk name: Biofilm formation
type: Risk
comment: Accumulation of bacterial biofilm on the implant surface.

Premature battery depletion
type: NamedIndividual
description: Battery end-of-life earlier than specified, risking therapy interruption
affected device type: Active_Implant_Type
has probability: Low_Probability_Type
has risk category: Device_Failure_Cat
has risk type: Malfunction_Rick_Type
has severity: Critical_Sev
imdrf code: A0501
risk name: Battery depletion - premature
type: Risk
comment: Unexpected battery failure prior to calculated end-of-life.

Software malfunction
type: NamedIndividual
description: Software bug causing incorrect dosing, alarming, or therapy delivery
affected device type: Active_Device_Type
has probability: Low_Probability_Type
has risk category: Device_Failure_Cat
has risk type: Software_Risk_Type
has severity: Critical_Sev
imdrf code: A0502
risk name: Software malfunction
type: Risk
comment: Critical software bug affecting therapy or dosing delivery.

Radiation overdose
type: NamedIndividual
description: Unintended ionising radiation exposure exceeding therapeutic dose
affected device type: Active_Device_Type
has probability: Low_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Radiaton_Risk_Type
has severity: Critical_Sev
imdrf code: A0601
risk name: Radiation overdose
type: Risk
comment: Risk of unintended ionising radiation exposure to patients.

MRI metallic artifact
type: NamedIndividual
description: Metallic implant causing MRI image artifacts compromising diagnostics
affected device type: Implantable_Type
has probability: High_Probability_Type
has risk category: Device_Performance_Cat
has risk type: Interference_Risk_Type
has severity: Moderate_Sev
imdrf code: A0701
risk name: Metallic artifact - MRI
type: Risk
comment: Formation of MRI artifacts compromising diagnostic quality.

Electromagnetic interference
type: NamedIndividual
description: External EMI affecting pacemaker/ICD sensing and pacing functions
affected device type: Active_Implant_Type
has probability: Low_Probability_Type
has risk category: Device_Performance_Cat
has risk type: Interference_Risk_Type
has severity: Serious_Sev
imdrf code: A0702
risk name: Electromagnetic interference
type: Risk
comment: External EMI interference affecting active implant functions.

False positive diagnostic
type: NamedIndividual
description: IVD test returns positive result in absence of target condition
affected device type: In_Vitro_Diagnostic_Device_Type
has probability: Medium_Probability_Type
has risk category: Diagnostic_Error_Cat
has risk type: Diagnostic_Risk_Type
has severity: Serious_Sev
imdrf code: B0101
risk name: False positive result
type: Risk
comment: Diagnostic risk of reporting a condition when none is present.

False negative diagnostic
type: NamedIndividual
description: IVD test fails to detect target condition in affected individual
affected device type: In_Vitro_Diagnostic_Device_Type
has probability: Low_Probability_Type
has risk category: Diagnostic_Error_Cat
has risk type: Diagnostic_Risk_Type
has severity: Critical_Sev
imdrf code: B0102
risk name: False negative result
type: Risk
comment: Diagnostic risk of failing to detect a target condition.

Reagent cross-reactivity
type: NamedIndividual
description: Reagent reacts with non-target analyte producing incorrect result
affected device type: In_Vitro_Diagnostic_Device_Type
has probability: Medium_Probability_Type
has risk category: Diagnostic_Error_Cat
has risk type: Diagnostic_Risk_Type
has severity: Serious_Sev
imdrf code: B0201
risk name: Cross-reactivity
type: Risk
comment: Reagent cross-reactivity leading to incorrect test results.

Reagent contamination
type: NamedIndividual
description: Reagent lot contamination leading to systematic Diagnostic_Error_Cats
affected device type: In_Vitro_Diagnostic_Device_Type
has probability: Low_Probability_Type
has risk category: Product_Quality_Type
has risk type: Contamination_Risk_Type
has severity: Critical_Sev
imdrf code: B0301
risk name: Contamination - reagent
type: Risk
comment: Reagent contamination causing systematic diagnostic errors.

Cybersecurity vulnerability
type: NamedIndividual
description: Exploitable software vulnerability enabling unauthorized device access
affected device type: Active_Device_Type
has probability: Low_Probability_Type
has risk category: Device_Safety_Cat
has risk type: Cybersecurity_Risk_Type
has severity: Critical_Sev
imdrf code: B0401
risk name: Cybersecurity vulnerability
type: Risk
comment: Software vulnerability allowing unauthorized device access.

Joint wear debris
type: NamedIndividual
description: Particulate debris from bearing surfaces causing adverse tissue reaction
affected device type: Implantable_Type
has probability: Medium_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Material_Risk_Type
has severity: Serious_Sev
imdrf code: C0101
risk name: Wear debris - joint implant
type: Risk
comment: Tissue reaction caused by particulate debris from implants.

Metallic corrosion
type: NamedIndividual
description: Metallic ion release from corrosion causing local or systemic toxicity
affected device type: Implantable_Type
has probability: Low_Probability_Type
has risk category: Patient_Harm_Cat
has risk type: Material_Risk_Type
has severity: Serious_Sev
imdrf code: C0201
risk name: Corrosion - metallic implant
type: Risk
comment: Local or systemic toxicity due to metallic ion corrosion.

Radiation Risk
type: Class
comment: A risk related to exposure to harmful radiation emitted by a device.
subclass of: Risk Type

Radiaton_Risk_Type
type: NamedIndividual
type: Radiation Risk
comment: Instance used to specify the hazard.

Recall
type: Class
comment: A corrective action involving the removal of a medical device from the market or its return due to safety concerns.
subclass of: Action Type

Recall_Type
type: NamedIndividual
type: Recall
comment: Instance representing the removal of a device from the market.

Risk
type: Class
comment: A potential hazard associated with a medical device, classified according to IMDRF terminology.
same as: http://dbpedia.org/resource/Risk
subclass of: Restriction
  cardinality: 1
  on property: affected device type
subclass of: Restriction
  cardinality: 1
  on property: has probability
subclass of: Restriction
  cardinality: 1
  on property: has risk category
subclass of: Restriction
  cardinality: 1
  on property: has risk type
subclass of: Restriction
  cardinality: 1
  on property: has severity
subclass of: Restriction
  cardinality: 1
  on property: description
subclass of: Restriction
  cardinality: 1
  on property: imdrf code
subclass of: Restriction
  cardinality: 1
  on property: risk name

Risk Category
type: Class
comment: A category grouping different types of risks.

Risk Type
type: Class
comment: The type of risk associated with a medical device.

Safety Alert
type: Class
comment: A notification issued to inform users about potential safety issues related to a medical device.
subclass of: Action Type

Safety_Alert_Type
type: NamedIndividual
type: Safety Alert
comment: Value used to categorize notifications regarding critical safety updates to users.

Self Test Device
type: Class
comment: A device intended to be able to be used by people without special knowledge.
subclass of: Device Type

Self_Test_Device_Type
type: NamedIndividual
type: Self Test Device
comment: Device category used to define its use.

Serious
type: Class
comment: A severity level indicating significant health impact or injury.
subclass of: Severity Level

Serious Incident
type: Class
comment: An incident that led or could lead to serious deterioration of health or death.
subclass of: Incident Type

Serious_Incident_Type
type: NamedIndividual
type: Serious Incident
comment: Instance used to flag events resulting in death or serious problems.

Serious_Sev
type: NamedIndividual
type: Serious
comment: Value used to show severity.

Severity Level
type: Class
comment: The level of severity associated with a risk.

Single Use Device
type: Class
comment: A device intended to be used on one individual during a single procedure.
subclass of: Device Type

Single_Use_Device_Type
type: NamedIndividual
type: Single Use Device
comment: Device category used to define its use.

Software Risk
type: Class
comment: A risk caused by software errors, bugs, or failures in a medical device.
subclass of: Risk Type

Software_Risk_Type
type: NamedIndividual
type: Software Risk
comment: Instance used to specify the hazard.

User Notice
type: Class
comment: A notification issued to users with instructions or information regarding the safe use of a medical device.
subclass of: Action Type

User_Notice_Type
type: NamedIndividual
type: User Notice
comment: Represents the specific notice sent to the user.

action date
type: DatatypeProperty
type: FunctionalProperty
comment: Date when the corrective action was initiated.
domain: Corrective Action
range: date

affected device type
type: DatatypeProperty
type: FunctionalProperty
comment: The type of the device related.
domain: Risk
range: string

affected device type
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Specifies the type of affected device.
domain: Risk
range: Device
inverse of: is affected type in

authorization number
type: DatatypeProperty
type: FunctionalProperty
comment: Official authorization number assigned to a manufacturer.
domain: Manufacturer
range: string

closure date
type: DatatypeProperty
type: FunctionalProperty
comment: Date when the corrective action was completed.
domain: Corrective Action
range: date

competent authority
type: DatatypeProperty
type: FunctionalProperty
comment: Authority responsible for regulatory oversight.
domain: Manufacturer
range: string

corrective action taken
type: DatatypeProperty
type: FunctionalProperty
comment: Indicates whether a corrective action has been taken in response to the incident.
domain: Incident
range: boolean

countries affected
type: DatatypeProperty
comment: Countries impacted by the corrective action.
domain: Corrective Action
range: string

country
type: DatatypeProperty
type: FunctionalProperty
comment: Country where the manufacturer is located.
domain: Manufacturer
range: string

country reported
type: DatatypeProperty
type: FunctionalProperty
comment: The country where the incident was reported.
domain: Incident
range: string

detection date
type: DatatypeProperty
type: FunctionalProperty
comment: The date when the incident or risk was first detected.
domain: Incident
range: date

device name
type: DatatypeProperty
type: FunctionalProperty
comment: The commercial name of the medical device.
domain: Device
range: string

devices affected
type: DatatypeProperty
comment: Number of devices impacted.
domain: Corrective Action
range: integer

eudamed f s c a ref
type: DatatypeProperty
type: FunctionalProperty
comment: Reference identifier of the corrective action in EUDAMED.
domain: Corrective Action
range: string

eudamed incident ref
type: DatatypeProperty
type: FunctionalProperty
comment: Reference identifier of the incident in EUDAMED.
domain: Incident
range: string

eudamed s r n
type: DatatypeProperty
type: FunctionalProperty
comment: Single Registration Number assigned in EUDAMED.
domain: Manufacturer
range: string

event date
type: DatatypeProperty
type: FunctionalProperty
comment: Date when the incident occurred.
domain: Incident
range: date

has action type
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Specifies the type of corrective action.
domain: Corrective Action
range: Action Type
inverse of: is action type of

has corrective action
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links an incident with its corrective action.
domain: Incident
range: Corrective Action
inverse of: related to incident

has device type
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: The type of the device.
domain: Device
range: Device Type
inverse of: is device type of

has incident recorded
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a device with its known incidents.
domain: Device
range: Incident
inverse of: involves device

has incident type
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Specifies the type of an incident.
domain: Incident
range: Incident Type
inverse of: is incident type of

has manufacturer
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a device to the manufacturer responsible for it.
domain: Device
range: Manufacturer
inverse of: is manufacturer of

has probability
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Indicates how likely a risk is to occur.
domain: Risk
range: Probability Level
inverse of: is probability of

has reported
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Relates an organization to the incidents they have reported.
domain: Manufacturer
range: Incident
inverse of: reported by

has risk
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Associates an incident with a specific risk.
domain: Incident
range: Risk
inverse of: is manifested in

has risk category
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Specifies the category of a risk.
domain: Risk
range: Risk Category
inverse of: is risk category of

has risk class
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Defines the regulatory risk classification of a device.
domain: Device
range: Device Risk Class
inverse of: is risk class of

has risk type
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Specifies the type of risk.
domain: Risk
range: Risk Type
inverse of: is risk type of

has severity
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Indicates the severity level of a risk.
domain: Risk
range: Severity Level
inverse of: is severity of

imdrf code
type: DatatypeProperty
type: FunctionalProperty
comment: Code assigned according to IMDRF risk classification.
domain: Risk
range: string

intended purpose
type: DatatypeProperty
type: FunctionalProperty
comment: The intended use of the device.
domain: Device
range: string

involves device
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Associates an incident with the device involved.
domain: Incident
range: Device

is action type of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links the type of a corrective measure to its actions.
domain: Action Type
range: Corrective Action

is active
type: DatatypeProperty
type: FunctionalProperty
comment: Indicates whether the device requires energy to operate.
domain: Device
range: boolean

is affected type in
type: ObjectProperty
comment: Relates a device type to the incidents or actions that have affected that category.
domain: Device
range: Risk

is device type of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Connects a device type to its medical devices.
domain: Device Type
range: Device

is i v d
type: DatatypeProperty
type: FunctionalProperty
comment: Indicates whether the device is an in vitro diagnostic device.
domain: Device
range: boolean

is implantable
type: DatatypeProperty
type: FunctionalProperty
comment: Indicates whether the device is implantable.
domain: Device
range: boolean

is incident type of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links an incident type to the incidents.
domain: Incident Type
range: Incident

is manifested in
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a risk with its possible incidents.
domain: Risk
range: Incident

is manufacturer of
type: ObjectProperty
type: InverseFunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a manufacturer with its devices.
domain: Manufacturer
range: Device

is probability of
type: ObjectProperty
type: InverseFunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Relates a probability level to a specific risk.
domain: Probability Level
range: Risk

is reusable
type: DatatypeProperty
type: FunctionalProperty
comment: Indicates whether the device can be reused.
domain: Device
range: boolean

is risk category of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a risk category its risks.
domain: Risk Category
range: Risk

is risk class of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Relates a risk class to its devices.
domain: Device Risk Class
range: Device

is risk type of
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Connects a risk type to the risks that have that type.
domain: Risk Type
range: Risk

is severity of
type: ObjectProperty
type: InverseFunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Connects a severity value with the risk that have its value.
domain: Severity Level
range: Risk

outcome
type: DatatypeProperty
type: FunctionalProperty
comment: Result or consequence of the incident.
domain: Incident
range: string

patient age
type: DatatypeProperty
type: FunctionalProperty
comment: Age of the patient involved in the incident.
domain: Incident
range: integer

patient sex
type: DatatypeProperty
type: FunctionalProperty
comment: Sex of the patient involved.
domain: Incident
range: string

regulatory framework
type: DatatypeProperty
type: FunctionalProperty
comment: The regulatory framework under which the device is classified, MDR or IVDR.
domain: Device
range: string

related to incident
type: ObjectProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Links a corrective action to the incident it addresses.
domain: Corrective Action
range: Incident

report date
type: DatatypeProperty
type: FunctionalProperty
comment: Date when the incident was reported.
domain: Incident
range: date

reported by
type: ObjectProperty
type: FunctionalProperty
type: AsymmetricProperty
type: IrreflexiveProperty
comment: Indicates the manufacturer that reported the incident.
domain: Incident
range: Manufacturer

risk name
type: DatatypeProperty
type: FunctionalProperty
comment: Name describing the risk.
domain: Risk
range: string

scope
type: DatatypeProperty
type: FunctionalProperty
comment: Scope of the corrective action.
domain: Corrective Action
range: string

status
type: DatatypeProperty
type: FunctionalProperty
comment: Current status of the corrective action.
domain: Corrective Action
range: string

udi_di
type: DatatypeProperty
type: FunctionalProperty
comment: The unique device identifier.
domain: Device
range: string

email
type: DatatypeProperty
comment: The contact email address of the manufacturer.
domain: Manufacturer
range: string

name
type: DatatypeProperty
type: FunctionalProperty
comment: The official name of the manufacturer.
domain: Manufacturer
range: string