Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator
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.
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly. Stryker anticipates that all devices subject to this field action will be serviced by December 31, 2019. If a customer experiences this issue, they should contact Stryker as soon as possible at 1 800 442 1142 and selecting option 7.
Since the initial commercialization of LIFEPAK 15 in 2009, Stryker has become aware of 58 complaints reported globally for this issue, including 6 events in which the patient died following a delay in therapy. In all six of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition. There are 13,003 devices potentially impacted by this issue and within scope of this field action.