Reporting & Handling Medical Device Failures

Did a medical device fail to perform as required or function within the proper specifications of intended use?

Medical device(s) involved

Patient response to incident

Was the device removed from use immediately?

Was the device sent for evaluation to a qualified engineering department or facility, with all pertinent device documentation?

Has a complete event report been completed, documenting all relevant details of the occurrence including patient specifics?

Was the completed report sent to the appropriate FDA action office within 48 hours of the incident?