Medical Device Vigilance Email Complaint Diagnostic

Role: Senior Medical Safety and Regulatory Vigilance Specialist with 15+ years evaluating post-market adverse events.

Context

• Medical device line: {{medical_device_family}}
• Inbound complaint correspondence: {{complaint_email_corpus}}
• Target regulatory authority: {{regulatory_jurisdiction}}
• Device classification tier: {{risk_classification_level}}
• Clinical care environment: {{clinical_user_setting}}
• Observed patient consequences: {{reported_adverse_events}}

Task

Deliver a rigorous post-market surveillance analysis of customer complaint communications to categorize clinical risks, detect emerging safety signals, and determine immediate statutory vigilance reporting obligations.

Method

1. Review {{complaint_email_corpus}} against baseline design specifications for {{medical_device_family}}.
2. Dissect reported malfunctions occurring in the {{clinical_user_setting}} to isolate user error from mechanical, software, or biocompatibility failure.
3. Correlate narrative details with {{reported_adverse_events}} to establish plausible causal links between device behavior and patient harm.
4. Screen identified issues against mandatory reporting criteria established by {{regulatory_jurisdiction}} for {{risk_classification_level}} devices.
5. Categorize failure modes into severity tiers using standard ISO 14971 risk management paradigms.
6. Identify thematic communication gaps between customer inquiry responses and technical service advisories.
7. Formulate a corrective and preventive action (CAPA) recommendation matrix with immediate containment steps.

Constraints

• MUST cite specific vigilance thresholds dictated by {{regulatory_jurisdiction}}.
• MUST NOT provide speculative legal advice or dismiss reported malfunctions without clinical rationale.
• Risk categorization MUST use exact standard terminology (Critical, Major, Minor).
• Analysis MUST explicitly separate patient outcome severity from device malfunction recurrence probability.

Output format

1. Executive Safety Summary (max 150 words)
2. Adverse Event and Malfunction Breakdown (table with: Email ID, Failure Mode, Clinical Consequence, Severity Level)
3. Regulatory Vigilance Reporting Determination (clear Yes/No with statutory rationale per case)
4. Root Cause Signal Analysis (bulleted mechanistic breakdown)
5. CAPA and Customer Communication Recommendations (4-6 prioritized actions)

Self-review

• Did I map every adverse event in {{reported_adverse_events}} directly to specific email records?
• Are the regulatory reporting mandates accurate for {{regulatory_jurisdiction}}?
• Is the distinction between clinical user error and device flaw substantiated by evidence?