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Judgment & ambiguity · When to escalate

A cluster of field complaints on one product line describes a symptom that could be a device malfunction contributing to patient harm — or could be user error. The reportability clock may already be running. When does this stop being a complaint-handling decision and become an escalation?

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The reportability clock doesn't wait for me to be certain, so I treat the ambiguity itself as the trigger.

The full answer: structure, worked example, likely follow-up.

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