Evaluate device incidents systematically determining regulatory reporting requirements and actions.
Criteria | Response |
---|---|
Does the event meet the definition of an incident according to Art. 2(64) MDR? | Yes - Software malfunction preventing completion of intended analysis |
Does the incident directly or indirectly lead to serious outcomes? | Deterioration of state of health - Patient required emergency medical care |
Has causal relationship been established or is suspected? | Yes - App failure prevented timely cardiac assessment |
Explanation | The software crash constituted a malfunction that prevented the device from completing its intended ECG analysis. While the patient’s emergency care was not directly caused by the device failure, the inability to complete the cardiac assessment may have contributed to delayed recognition of the patient’s condition. |
Is this considered a reportable incident? | Yes - All three criteria are met |
Category | Information |
---|---|
Event Description | Mobile ECG app (v2.3.1) crashed during heart rhythm analysis at 14:32 on March 15, 2024. Error code: “Memory allocation failure during signal processing.” Patient was analyzing 30-second ECG recording when app terminated unexpectedly. |
Source of Event | Customer complaint via support email, confirmed by device logs uploaded automatically |
Location of Event | Patient’s home in Munich, Germany |
Date and Time Event Reported | March 16, 2024 at 09:15 CET via customer support |
Product and Version Affected | CardioWatch Mobile App v2.3.1, Build 2024.03.01 |
Planned Actions | Immediate: Release hotfix v2.3.2 addressing memory allocation issue. FSCA: Issue Field Safety Notice to all users recommending app update. Preventive: Implement additional memory management testing in QA processes. |
Relevant Competent Authorities | BfArM (Germany) - primary incident location; ANSM (France), AIFA (Italy) - other EU markets where device is sold |
What should be done if a new risk is identified during the vigilance database review?
How should complaints be managed in relation to incident assessment?
What is the difference between reportable and non-reportable incidents?
How quickly must incident assessments be completed?
Should software malfunctions always be considered incidents?