displayName
Patient Safety Event Review
workflowKind
governance
triggerType
event-driven
typicalCadence
per-event
complexity
cross-team
description
Reviews reported patient safety events and adverse incidents -- triaging
incoming event reports by severity classification, conducting root-cause
analysis with clinical and engineering teams, correlating device
telemetry or software logs with patient outcomes, evaluating whether
corrective action is required, and filing regulatory reports (FDA
MedWatch, MHRA Yellow Card) within mandated timelines. Produces incident
investigation reports, corrective action plans, and regulatory
submission records. Excludes clinical treatment decisions.