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MEDICAL-DEVICE-BASICS5 MIN READ

From Complaint to MDR Question

Triage a complaint signal into information gathering, MDR reportability review, and escalation.

The ticket Pump stopped overnight; patient went to ER. A support ticket can contain a reportability question even when causality is unclear. MDR triage Preserve facts, escalate quickly The intake role is to capture the event, patient outcome, device identity, and availability for evaluation, then route for reportability review. Shortcut Close as battery issue A reviewable safety record Unclear causality is a reason to gather facts, not a reason to close the signal. Open the record Step 1 The customer replaced the battery and wants a refund. What should the support agent do first? Ask reportability facts Step 2 The…

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