Does a Medical Device Manufacturer Have to Report All Malfunctions of a Device?

• By: Staff Editor
• Date: December 15, 2011

No – not all medical device malfunctions have to be reported by a manufacturer. If they are not likely to result in death, serious injury or other significant adverse event experiences, malfunctions need not be reported.

A malfunction that is found or corrected during routine service of the device must be reported if its recurrence is likely to cause or contribute to death or serious injury.

If any of the following happens, then a malfunction is considered reportable:

1. The chance of death or serious injury occurring as a result of a recurrence of the malfunction is not remote;
2. The malfunction affects the device in a catastrophic manner and may lead to the death or serious injury of the patient using it;
3. It causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness. This in turn can contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device's labeled use, but for any use widely prescribed in medical practice;
4. It involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used;
5. There is malfunction in the device considered life-supporting or life-sustaining, and essential to maintaining human life; or
6. The manufacturer is required to take action under section 518 or 519(f) of the FD&C Act as a result of the malfunction of the device.

Read the best practices that medical device manufacturers must follow in the medical device reporting (MDR) process.