Medical Device Failure or Malfunction Policy Term Definition

failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if:

• the chance of a death or serious injury resulting from a recurrence of the malfunction is not remote;
• the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury;
• the malfunction causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness which could cause or 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 within the practice of medicine;
• the malfunction involves a long-term device implant that would prevent the implant from performing its function;
• the device is considered life-supporting or life-sustaining, and thus essential to maintaining human life; or
• the manufacturer takes, or would be required to take an action under section 518 or 519(g) of the FD&C Act as a result of the malfunction of the device or other similar devices.