Question

A nurse suspects that a patient’s death is due to a medical device with a manufacturing defect. What should the nurse do?

Keep the information quiet.

Call the local news station.

File a report with the hospital, the device manufacturer, and the FDA.

Continue using the device until she is sure that the device caused the patient’s death.

Answer 1

File a report with the hospital, the device manufacturer, and the FDA.

Rationale and recommended steps:
- Healthcare facilities (user facilities) are required to report suspected device‑related deaths/serious injuries to the facility’s risk/patient‑safety office and to the FDA and device manufacturer (promptly; regulations generally require reporting within 10 working days for deaths).
- Do not conceal the event or wait until you’re certain — timely reporting is required even when a device only may have contributed.
- Preserve the device, packaging, relevant records, and patient chart for investigation; remove the device from use if indicated by facility policy.
- Follow your facility’s incident reporting procedures, document everything in the medical record, and notify risk management/patient safety. You (or the facility) can report to the FDA via MedWatch/MDR.