Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.
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The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.
Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.
Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.
Find the full press release on the FDA website.