Medical Device Adverse Event Escalation Checklist

Role: Medical Device Post-Market Vigilance Manager

Context

• Device Product Family: {{device_family}}
• Complaint Tracking ID: {{incident_reference}}
• Reported Harm Level: {{patient_harm_level}}
• Clinical Facility: {{facility_contact}}
• Relevant Regulatory Body: {{regulatory_agency}}
• Immediate Containment Status: {{containment_action_status}}

Task

Generate a post-market surveillance escalation checklist to evaluate product malfunction risk, quarantine affected inventory, initiate regulatory vigilance reporting, and secure device return for failure analysis.

Method

1. Assess the technical failure mode reported for {{device_family}} in reference to {{incident_reference}}.
2. Classify reportability thresholds according to {{patient_harm_level}} under {{regulatory_agency}} guidelines (e.g., FDA MDR or EU MDR).
3. Define isolation protocols based on {{containment_action_status}} to halt use of matching lot numbers at {{facility_contact}}.
4. Outline the chain-of-custody checklist for retrieving the explanted or malfunctioning device for root-cause analysis.
5. Coordinate escalation pathways connecting Customer Support, Quality Engineering, and Regulatory Affairs.
6. Establish documentation requirements for the internal Health Hazard Evaluation (HHE) and risk management file.
7. Prepare formal submission gates to meet strict mandatory vigilance reporting timeframes.

Constraints

• MUST adhere strictly to medical device reporting (MDR) nomenclature.
• Chain-of-custody items MUST mandate physical evidence preservation and decontamination protocols.
• MUST NOT conclude root cause prior to physical engineering evaluation.
• Every checklist phase MUST specify an operational time limit (e.g., <4 hours, <24 hours).

Output format

• Triage Overview (bulleted summary of complaint metadata and vigilance risk)
• Immediate Site Containment & Device Retrieval Checklist (3-4 items)
• Regulatory Vigilance & Reporting Checklist (3-4 items)
• Quality Engineering & Risk Evaluation Checklist (3-4 items)
• Account Follow-up & Documentation Checklist (2-3 items)

Self-review

• Verify that regulatory reporting triggers correspond accurately to {{patient_harm_level}}.
• Confirm that chain-of-custody steps protect evidence integrity for {{device_family}}.
• Check that all checklist entries have actionable checkboxes [ ] and clear completion criteria.