Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 Monitor/Defibrillators.
According to the FDA announcement, 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.
Acadian Ambulance confirmed for KATC that they have about 110 of the specific units impacted by the notice, said C. Randall Mann, Vice President of Marketing & Public Relations for Acadian Companies.
Acadian hasn’t had any instances of equipment failure, but is conducting the recommended test on each unit, he said. Stryker has sent instructions for users to detect the error, Mann said. The company is providing a software update that should solve the problem, according to information sent by Stryker to Acadian.
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, the announcement states. 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.
To see the FDA’s complete announcement on the units, click here.