Question

When a medical device malfunctions or is suspected to have a defect, a healthcare worker is required to
repair the device using the equipment manual.
inspect the device for compliance with local regulations.
calibrate the device using known measurements.
report the device to the manufacturers and federal authorities.

Answer 1

Correct answer: report the device to the manufacturer and the appropriate regulatory authorities.

Explanation and what to do immediately:
- Do not attempt to repair, calibrate, or return the device to service yourself unless you are authorized and trained to do so. Unqualified work can create safety and legal issues.
- Remove the device from use, label/tag it as malfunctioning, and isolate it so it cannot be used.
- Notify your supervisor and your facility’s biomedical engineering/clinical engineering or risk-management department.
- Document the event in the patient and facility records (what happened, patient effect, device ID/serial number, time, personnel involved).
- Follow your facility’s incident-reporting procedures and file mandatory reports to the manufacturer and the appropriate regulatory body (e.g., FDA MedWatch and/or local health authority) as required by local law and 21 CFR 803 (in the U.S.).

If you want, I can give a step‑by‑step checklist or sample wording for a MedWatch/manufacturer report.