This section captures essential identification and traceability information for the affected device and reporting healthcare institution. Complete all fields with exact values from device labeling and facility records.
Device Model Number
Device Serial Number
Device Firmware Version
Hardware Revision Level
Device Manufacturing Date
Date of Device Installation/Commissioning at Facility
Date of Last Preventive Maintenance
Healthcare Facility Legal Entity Name
Facility Department/Unit Where Device is Used
Facility Contact Person Full Name
Contact Person Professional Title/Credentials
Contact Person Direct Phone Number
Contact Person Official Email Address
Facility Accrediting Body Identifier
Is the device part of a networked system or standalone?
Associated Accessories or Consumables Used During Incident
Accessory/Consumable Name | Part Number | Lot/Batch Number | Expiration Date | Suspected Role in Malfunction? | |
|---|---|---|---|---|---|
Provide a comprehensive narrative of the device malfunction and any resulting patient impact. This section is critical for risk assessment and regulatory determination. Be precise and include all observable symptoms and consequences.
Detailed Description of Malfunction or Observed Defect
Exact Date and Time of Malfunction Discovery
Device Operational Mode When Malfunction Occurred
Was the device actively involved in patient treatment when the malfunction occurred?
Did the malfunction result in any direct or indirect patient harm, injury, or adverse outcome?
Potential Severity of Harm (if no actual harm occurred)
Patient Outcome Narrative (if applicable)
Number of Patients Potentially Exposed to Malfunctioning Device
Was alternative equipment or manual procedure successfully implemented?
Has this specific malfunction been reported to any regulatory authority?
Regulatory Reporting Obligation Assessment (per internal policy)
Reportable Serious Incident (Immediate)
Reportable Incident (Timeline)
Non-Reportable (Internal Tracking Only)
Undetermined (Requires Further Review)
Upload Device Error Logs or System Dump Files
Upload Photographs of Device Display, Error Screens, or Physical Damage
Upload Patient Monitoring Data or Treatment Records (if applicable and legally permissible)
This section ensures proper physical control of the suspect device to preserve forensic evidence and prevent further use. Complete all steps before device transport.
Has the device been physically removed from service and tagged as 'Quarantined - Do Not Use'?
Is there any suspicion of biological, chemical, or radioactive contamination on the device?
Has the device been properly decontaminated per facility protocol?
Are all original accessories, cables, and consumables being returned with the device?
Physical Condition of Device at Time of Quarantine
Has a secure chain of custody been established for device transport?
Scheduled Pickup Date for Device Return
Priority Level for Device Return Shipment
Emergency Same-Day Courier
Next Business Day Express
Standard 2-3 Day
Scheduled with Next Field Service Visit
Has a replacement device been provided to the facility?
Upload Completed Quarantine Tag Photograph
Upload Decontamination Certificate or Verification Record
This section initiates the systematic investigation process to identify root cause and determine appropriate corrective and preventive actions. Assign responsibilities and timelines for each action item.
Preliminary Root Cause Hypothesis Category
Hardware Component Failure
Software/Firmware Defect
User Error/Training Issue
Maintenance/Service Procedure Deficiency
Design Flaw
Manufacturing Defect
Environmental/Usage Condition Exceeded
Unknown/Requires Detailed Analysis
Risk Assessment Matrix: Assign probability and severity scores
Probability of Recurrence (1=Very Unlikely, 5=Certain) | |
Severity of Potential Harm (1=No Harm, 5=Death) | |
Detectability Before Harm (1=Always Detected, 5=Never Detected) | |
Number of Devices in Field with Similar Risk Profile |
Calculated Risk Priority Number (RPN = Probability x Severity x Detectability)
CAPA Classification (select all that apply)
Corrective Action (Fix Current Issue)
Preventive Action (Stop Future Occurrence)
Field Safety Corrective Action (FSCA)
Field Safety Notice (FSN)
Software Update Required
Hardware Modification Required
Training Enhancement
Labeling/IFU Update
No Action Required (Information Only)
Does this issue warrant a field-wide safety notification or recall?
Investigation Team Assignment & Timeline
Team Member Name | Role/Department | Investigation Task | Assigned Date | Target Completion Date | Priority (1=Low, 5=Critical) | |
|---|---|---|---|---|---|---|
Are there any similar complaints or trends in the complaint database?
Immediate Interim Containment Actions Taken
Target Date for Final Investigation Report Completion
Final governance and accountability section. All assessments must be reviewed and approved by designated authority before case closure. Electronic signatures constitute formal approval.
Has Regulatory Affairs reviewed and confirmed reporting obligations?
Regulatory Affairs Justification for Reporting Determination
Does this investigation trigger any post-market surveillance reporting (e.g., Periodic Safety Update Report)?
Regulatory Affairs Director Full Name
Regulatory Affairs Director Professional Credentials
Regulatory Affairs Director Electronic Signature
Regulatory Affairs Director Sign-Off Date/Time
Quality Assurance Head Full Name
Quality Assurance Head Professional Credentials
Quality Assurance Head Electronic Signature
Quality Assurance Head Sign-Off Date/Time
Do both directors agree that investigation is complete and all actions are appropriate?
Final Case Disposition Status
Closed - All Actions Complete
Open - Awaiting Device Analysis
Open - Regulatory Submission Pending
Open - CAPA Implementation in Progress
Referred to Management Review Board
Investigation Case Number