FDA posted a Stryker announcement today that the company is launching a voluntary field action (VFA) on specific units of the LIFEPAK 15 Monitor/Defibrillators.
The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.
Often, software errors can be the cause of lock-up conditions, but they can be difficult to track down during system level testing. One source of help to the designer is IEC 80002-1, which provides guidance on good design and verification methods for many categories of failure modes including lock-ups. See other posts on 80002-1.