Noël García Pou (2026) - Medical Devices Ontology - UOC Project
European high-risk medical devices.
PAC2 - Medical Devices and Incidents
Project submission
Specifies the type of affected device.
affected device type
Specifies the type of corrective action.
Links an incident with its corrective action.
has corrective action
The type of the device.
Links a device with its known incidents.
has incident recorded
Specifies the type of an incident.
Links a device to the manufacturer responsible for it.
Indicates how likely a risk is to occur.
Relates an organization to the incidents they have reported.
has reported
Associates an incident with a specific risk.
Specifies the category of a risk.
Defines the regulatory risk classification of a device.
Specifies the type of risk.
Indicates the severity level of a risk.
Associates an incident with the device involved.
Links the type of a corrective measure to its actions.
is action type of
Relates a device type to the incidents or actions that have affected that category.
Connects a device type to its medical devices.
is device type of
Links an incident type to the incidents.
is incident type of
Links a risk with its possible incidents.
is manifested in
Links a manufacturer with its devices.
is manufacturer of
Relates a probability level to a specific risk.
is probability of
Links a risk category its risks.
is risk category of
Relates a risk class to its devices.
is risk class of
Connects a risk type to the risks that have that type.
is risk type of
Connects a severity value with the risk that have its value.
Links a corrective action to the incident it addresses.
Indicates the manufacturer that reported the incident.
Date when the corrective action was initiated.
The type of the device related.
Official authorization number assigned to a manufacturer.
Date when the corrective action was completed.
Authority responsible for regulatory oversight.
Indicates whether a corrective action has been taken in response to the incident.
Countries impacted by the corrective action.
Country where the manufacturer is located.
The country where the incident was reported.
The date when the incident or risk was first detected.
The commercial name of the medical device.
Number of devices impacted.
Reference identifier of the corrective action in EUDAMED.
Reference identifier of the incident in EUDAMED.
Single Registration Number assigned in EUDAMED.
Date when the incident occurred.
Code assigned according to IMDRF risk classification.
The intended use of the device.
Indicates whether the device requires energy to operate.
Indicates whether the device is an in vitro diagnostic device.
Indicates whether the device is implantable.
Indicates whether the device can be reused.
Result or consequence of the incident.
Age of the patient involved in the incident.
Sex of the patient involved.
The regulatory framework under which the device is classified, MDR or IVDR.
Date when the incident was reported.
Name describing the risk.
Scope of the corrective action.
Current status of the corrective action.
The unique device identifier.
The contact email address of the manufacturer.
The official name of the manufacturer.
The type of corrective action taken in response to an incident.
A medical device that relies on a source of energy other than the human body.
A surgically inserted medical device that relies on an external power source to function.
Risk Class A for in vitro diagnostic devices according to the IVDR framework.
Risk Class B for in vitro diagnostic devices according to the IVDR framework.
Risk Class C for in vitro diagnostic devices according to the IVDR framework.
Risk Class D for in vitro diagnostic devices according to the IVDR framework.
Risk Class I for medical devices according to the MDR framework.
Risk Class III for medical devices according to the MDR framework.
Risk Class IIa for medical devices according to the MDR framework.
Risk Class IIb for medical devices according to the MDR framework.
A risk associated with contamination of a device by biological, chemical, or other substances.
An action taken to manage a safety issue related to a medical device.
A severity level indicating life-threatening or fatal consequences.
A risk related to unauthorized access, data breaches, or cyber attacks affecting a medical device.
A medical device used for diagnostic or therapeutic purposes
A risk category related to malfunction or failure of a medical device.
A risk category related to issues affecting the performance of a medical device.
A classification level indicating the risk associated with a medical device.
A risk category concerning the safety aspects of a medical device.
The type of the device
Device Type
A risk category involving incorrect diagnostic results produced by a device.
A risk involving incorrect or unreliable diagnostic results produced by a device.
A probability level indicating a high likelihood of occurrence.
An active device intended to be completely or partially introduced into the body.
A device intended to be placed inside the human body.
A corrective action performed directly on the device at its location without removing it.
A device used to perform tests on samples outside the human body
An event related to a medical device that may cause or has caused harm.
The classification of the reported incident.
A risk related to the potential transmission of infections through the use of a medical device.
A risk involving physical harm or injury to a patient or user caused by a device.
A risk caused by flaws in the interaction (physical, cognitive, or logical) between the person and the device.
A probability level indicating a low likelihood of occurrence.
A risk related to the failure or malfunction of a medical device.
An organization responsible for producing medical devices and registering them in EUDAMED.
A risk associated with the materials used in a device.
A probability level indicating a moderate likelihood of occurrence.
A severity level indicating moderate health impact requiring intervention.
A Near Miss incident involving a medical device.
A risk category involving injury or harm caused to a patient.
The likelihood of a risk occurring.
A risk category related to defects or quality issues in a medical device.
A risk related to exposure to harmful radiation emitted by a device.
A corrective action involving the removal of a medical device from the market or its return due to safety concerns.
A potential hazard associated with a medical device, classified according to IMDRF terminology.
A category grouping different types of risks.
The type of risk associated with a medical device.
A notification issued to inform users about potential safety issues related to a medical device.
A device intended to be able to be used by people without special knowledge.
A severity level indicating significant health impact or injury.
An incident that led or could lead to serious deterioration of health or death.
The level of severity associated with a risk.
A device intended to be used on one individual during a single procedure.
A risk caused by software errors, bugs, or failures in a medical device.
A notification issued to users with instructions or information regarding the safe use of a medical device.
Device category used to define its use.
Active_Implant_Type
Standardized classification values for In Vitro Diagnostic (IVD) devices.
Class_A
Class_B
Class_C
Class_D
Standardized risk classification values for General Medical Devices.
Class_I
Class_IIa
Instance used to specify the hazard.
Value used to show severity.
Ventricular assist device for end-stage heart failure
Ventricular assist device for end-stage heart failure treatment.
HeartMate 3 LVAD
Leadless cardiac pacemaker for atrioventricular synchrony
Leadless cardiac pacemaker designed for atrioventricular synchrony.
Micra AV Transcatheter Pacing System
Transcatheter aortic valve replacement (TAVI)
Transcatheter aortic valve replacement system for TAVI procedures.
Portico Transcatheter Heart Valve
Drug-eluting coronary stent system for cardiovascular intervention.
Quadripolar LV lead for cardiac resynchronization therapy.
Peripheral artery drug-coated angioplasty balloon
Drug-coated angioplasty balloon for peripheral artery treatment.
High-performance diagnostic ultrasound imaging system.
3T magnetic resonance imaging system for advanced diagnostics.
Total knee arthroplasty implant system for joint replacement.
Ceramic-on-ceramic total hip replacement
Ceramic-on-ceramic total hip replacement system.
Sustained-release fluocinolone acetonide ocular implant
Sustained-release intravitreal implant for ocular therapy.
Viva Cardiac Resynchronization Defibrillator
Cardiac resynchronization therapy with defibrillation
Cardiac resynchronization therapy device with defibrillation capacity.
ICU mechanical ventilator with pressure and volume modes
ICU mechanical ventilator with advanced ventilation modes.
Handheld point-of-care ultrasound diagnostic probe.
High-volume online hemodiafiltration machine
High-volume online hemodiafiltration machine for renal care.
Automated immunoassay analyzer for clinical laboratory
Automated immunoassay analyzer for clinical laboratory use.
Molecular diagnostic test for SARS-CoV-2 detection
Molecular diagnostic test kit for SARS-CoV-2 detection.
Combined HIV antigen and antibody detection assay.
Urine-based prostate cancer diagnosis assay
Urine-based assay for prostate cancer molecular diagnosis.
Non-invasive prenatal testing (NIPT) for aneuploidies
Non-invasive prenatal test for detecting genetic aneuploidies.
Continuous glucose monitor for patients with diabetes
Continuous glucose monitoring system for diabetic patients.
Portable patient monitor for vital signs
Portable patient monitor for real-time vital signs tracking.
Active cochlear implant for sensorineural hearing loss
Active cochlear implant system for sensorineural hearing loss.
Large volume infusion pump with drug library
Large volume infusion pump with integrated drug library.
Transcatheter mitral valve replacement system
Transcatheter mitral valve replacement system.
Instance used to group risks by their area of impact.
All HeartMate 3 LVAD units implanted since 2020
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.
Safety alert regarding anticoagulation protocol updates.
Micra AV lots manufactured between 2022-09 and 2023-03
Voluntary Recall_Type of affected Micra AV lots due to premature battery depletion. Replacement units provided. 97% of affected devices successfully replaced.
Voluntary recall of specific lots due to battery issues.
Portico THV sizes 23mm and 25mm from lots before 2023-11
Enhanced deployment training and updated IFU for Portico valve implantation technique. New implantation checklist mandatory for all TAVI centres.
Field correction involving updated implantation techniques.
Safety communication to implanting cardiologists regarding optimal fixation technique for ACUITY X4 lead. Enhanced fluoroscopy verification protocol at implantation.
Communication on optimal fixation techniques for cardiac leads.
Persona Knee tibial inserts with lot numbers PN-2019-* to PN-2021-*
Enhanced surveillance programme: annual DEXA scan and serum particle monitoring for patients with affected tibial inserts. Patients contacted individually.
Enhanced surveillance programme for patients with joint implants.
TRITON Total Hip ceramic-on-ceramic 28mm heads from lots TH-2020-* and TH-2021-*
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.
Urgent recall of hip implants due to metal ion release.
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.
Safety notice regarding updated MRI-conditional guidelines.
ATERA ventilators with software version 2.1.3
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.
Mandatory software update to correct ventilator calibration.
Customer field notification regarding biotin interference in TSH assay. Updated sample preparation protocol and interference screening algorithm released via software update 4.1.2.
Field notification regarding interference screening in assays.
cobas SARS-CoV-2 RT-PCR reagent lot numbers CV-2024-0312 to CV-2024-0318
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.
Immediate quarantine and replacement of diagnostic reagent lots.
All OPTIGA CGM sensors from manufacturing site GE-SGP-2
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.
Mandatory firmware update to improve sensor compensation.
Plum 360 infusion pumps with drug library version 4.2.1
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.
Urgent recall and software update for infusion pump drug library.
All HeartMate 3 LVAD units with outflow graft lot OG-2022-*
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.
Communication regarding outflow graft routing techniques.
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.
Updated clinical protocol for infection prophylaxis.
All 5008S hemodialysis machines with network connectivity module v2.x
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.
Deployment of security patch to disable unauthorized access.
Value used to show likelihood.
Serious_Sev patient injury - embolic stroke
Patient implanted with HeartMate 3 LVAD developed ischemic stroke 6 months post-implant. Device thrombus confirmed by echocardiography.
Serious injury involving embolic stroke and device thrombus.
Device malfunction - premature battery depletion
Micra AV pacemaker reached elective replacement indicator 14 months earlier than expected longevity specification.
Malfunction report regarding premature battery depletion.
Surgical intervention required - valve re-anchoring
Portico valve showed paravalvular leak grade III due to partial migration 2 weeks post-TAVI procedure.
Surgical intervention required due to valve migration.
SYNERGY stent fracture detected on angiography 18 months post-implant causing in-stent restenosis.
Detection of stent fracture causing in-stent restenosis.
Surgical intervention required - lead extraction
ACUITY X4 lead dislodgement to right ventricle requiring fluoroscopy-guided repositioning.
Incident involving lead dislodgement requiring repositioning.
Device malfunction - complete system failure
ACUSON Sequoia ultrasound system froze mid-examination. Emergency shutdown required; patient examination incomplete.
Complete system failure during patient ultrasound examination.
Patient_Harm_Cat - adverse tissue reaction
Persona knee tibial insert showing accelerated polyethylene wear with metallosis confirmed at 3-year revision surgery.
Adverse tissue reaction caused by accelerated component wear.
TRITON hip patient presented with elevated serum cobalt (18 ppb). Adverse local tissue reaction (ALTR) confirmed by MRI.
Report of cobalt toxicity and local tissue reaction.
Viva CRT-D delivered inappropriate ICD therapy during MRI scan despite MRI-conditional programming. Patient experienced pain and syncope.
Inappropriate ICD shock delivery during MRI procedure.
Device malfunction - incorrect FiO2 delivery
ATERA ventilator software version 2.1.3 delivered FiO2 6% lower than set value for patients in ARDS protocol. 3 patients affected.
Ventilator software error causing incorrect FiO2 delivery.
Diagnostic_Error_Cat - false positive TSH results
cobas e 801 thyroid-stimulating hormone (TSH) assay reported false positive results (>10 mIU/L) in 12 euthyroid patients due to biotin interference.
False positive results in TSH assay due to interference.
Diagnostic_Error_Cat - false negative SARS-CoV-2
cobas SARS-CoV-2 assay failed to detect Omicron BA.2.86 subvariant in 7 samples confirmed positive by sequencing. Lot-specific issue.
False negative results failing to detect SARS-CoV-2 subvariant.
Incident INC-012 (False negative SARS-CoV-2)
Diagnostic_Error_Cat - false negative HIV
VIDAS HIV DUO Ultra failed to detect HIV-1 group O infection in seroconversion panel. Patient missed early treatment window.
Missed detection of HIV-1 group O during seroconversion.
OPTIGA CGM sensor reported glucose 3.8 mmol/L while laboratory reference showed 14.2 mmol/L. Patient delayed insulin administration.
Hyperglycaemic event caused by incorrect CGM glucose reading.
Plum 360 infusion pump delivered 10x heparin dose due to software decimal point error in drug library version 4.2.1.
Critical drug overdose due to software decimal point error.
HeartMate 3 patient developed severe haemolysis (LDH >2000 U/L) associated with outflow graft kinking confirmed by CT.
Severe haemolysis associated with device graft kinking.
Iluvien implant required surgical removal due to device-related endophthalmitis confirmed by vitreous culture.
Device-related endophthalmitis requiring implant removal.
Cybersecurity incident - unauthorised access
5008S hemodialysis machine web interface exposed to hospital internal network. Unauthorised session accessed alarm configuration.
Cybersecurity vulnerability exposing device network interface.
Incident INC-018 (Cybersecurity vulnerability)
Near-miss - device not activated post-surgery
Tivoli II cochlear implant failed to respond to initial activation programming. Sound processor replacement resolved the issue.
Near-miss incident involving cochlear implant activation failure.
MAGNETOM Vida MRI caused localised skin burn (1st degree) at anterior electrode lead in patient with DBS system not declared prior to scan.
Localised skin burn during MRI scan due to SAR heating.
Represents the specific action of performing repairs or adjustments at the device's location.
Health Products Regulatory Authority (HPRA)
Global medical technology company based in Ireland.
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Major manufacturer of cardiovascular and diabetes care devices.
Leading provider of medical imaging and laboratory diagnostics.
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Healthcare technology company specializing in imaging and monitoring.
Multinational healthcare company focused on pharmaceuticals and diagnostics.
Manufacturer of medical devices used in interventional specialties.
Medical technology company focused on orthopaedics and spine surgery.
Specialist in cardio- and endovascular medical technology.
Provider of medical imaging, monitoring, and digital solutions.
Global leader in musculoskeletal healthcare and joint replacement.
Medicines and Healthcare products Regulatory Agency (MHRA)
Medical device company focused on cardiac surgery and neuromodulation.
International leader in medical and safety technology.
Agence nationale de sécurité du médicament (ANSM)
Global manufacturer of renal and vascular products.
Agence fédérale des médicaments et des produits de santé (AFMPS)
Medical technology company primarily focused on women's health.
World leader in the field of in vitro diagnostics.
Instance used to flag an event that did not cause harm but could have done.
Instance used to group risks by their area of impact.en
Complete loss of electrical function leading to device shutdown
Risk of complete electrical shutdown of the device.
Structural failure of mechanical components under physiological load
Risk of structural mechanical failure under physiological load.
Thrombus formation on device surface causing embolic events
Potential for thrombus formation on blood-contacting surfaces.
Mechanical destruction of red blood cells by pump mechanism
Risk of red blood cell destruction by mechanical pump action.
Unintended displacement of implant from intended anatomical position
Unintended migration of an implant from its original site.
Cardiac lead displacement requiring repositioning or replacement
Potential for cardiac lead displacement post-implantation.
Device-related infection at implantation site or systemic sepsis
Risk of infection or sepsis related to the medical device.
Bacterial biofilm accumulation on implant surface resistant to antibiotics
Accumulation of bacterial biofilm on the implant surface.
Battery end-of-life earlier than specified, risking therapy interruption
Unexpected battery failure prior to calculated end-of-life.
Software bug causing incorrect dosing, alarming, or therapy delivery
Critical software bug affecting therapy or dosing delivery.
Unintended ionising radiation exposure exceeding therapeutic dose
Risk of unintended ionising radiation exposure to patients.
Metallic implant causing MRI image artifacts compromising diagnostics
Formation of MRI artifacts compromising diagnostic quality.
External EMI affecting pacemaker/ICD sensing and pacing functions
External EMI interference affecting active implant functions.
IVD test returns positive result in absence of target condition
Diagnostic risk of reporting a condition when none is present.
IVD test fails to detect target condition in affected individual
Diagnostic risk of failing to detect a target condition.
Reagent reacts with non-target analyte producing incorrect result
Reagent cross-reactivity leading to incorrect test results.
Reagent lot contamination leading to systematic Diagnostic_Error_Cats
Reagent contamination causing systematic diagnostic errors.
Exploitable software vulnerability enabling unauthorized device access
Software vulnerability allowing unauthorized device access.
Particulate debris from bearing surfaces causing adverse tissue reaction
Tissue reaction caused by particulate debris from implants.
Metallic ion release from corrosion causing local or systemic toxicity
Local or systemic toxicity due to metallic ion corrosion.
Instance representing the removal of a device from the market.
Value used to categorize notifications regarding critical safety updates to users.
Safety_Alert_Type
Instance used to flag events resulting in death or serious problems.
Represents the specific notice sent to the user.
A textual description providing details about the incident or risk.