Stryker Lifepak 15 Urgent Medical Device Safety Notice and Correction

Office of Emergency Medical Services

DEPARTMENT OF PUBLIC HEALTH                                                                                                               

COMMONWEALTH OF MASSACHUSETTS

Notice

Stryker Lifepak 15 Urgent Medical Device Safety Notice and Correction

The Massachusetts Department of Public Health has been alerted that Stryker is conducting a voluntary Field Action for specific Lifepak 15 Monitor/Defibrillator devices that may lock-up after a defibrillation shock is delivered. This 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. For more information on this recall, or to check if other LIFEPAK 15 devices are affected by this Field Action, please go to the following website: http://www.strykeremergencycare.com/productnotices. Please also see attached letter from Stryker.

Stryker states the devices can be fixed in place with uploading a software modification and will be done at  the ambulance services themselves by a Stryker service representative.  There will also be some depot service offered based on customer need.  Given the very low number of these events, Stryker is not recommending that the devices be removed from service.  If your service experiences this issue, call Stryker immediately.