Certain Stryker defibrillators may lock up when needed for life-saving shock treatments, potentially increasing the risk of death or serious injury, according to a new warning.
On February 1, Stryker issued a letter to customers (PDF), indicating that it has received at least 58 complaints linked to Lifepak 15 Monitor/Defibrillator devices that locked up after a defibrillation shock was delivered. At least six deaths may be linked to the problems, and the letter seeks to provide information about how to deal with LifePack 15 defibrillators that “lock up”.
The devices are designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest. Electrodes are attached to a patient, analyze the patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when necessary. The devices are used in the medical field by trained professionals and commonly by medical emergency first responders.
According to Stryker Corporation, of Kalamazoo, Michigan, reports indicate the devices locked up and displayed a blank monitor with LED lights on, indicating there was power to the device. However, the blank screen would not allow the user to control the keyboard or device functions, posing a delay or failure to deliver shock treatments.
Stryker’s letter advises that in the event of a lock-up condition, medical professionals should press and hold the “ON” button for approximately five seconds until the LED light turns off, then press the “ON” button to power the device back on. If this does not work, medical professionals are being instructed to remove both batteries and disconnect the device from the power adapter, then reinsert the batters and power the device back on.
The FDA previously issued a Class I recall of Lifepak 15 defibrillators in 2010, when a subset of devices were found to spontaneously turn off during emergency shock treatment. The problem was found to involve an internal component in the defibrillators, which could inadvertently contact the power printed circuit board assembly. This scenario would cause the device to turn off and on by itself, or turn itself on and not respond to being turned back off.
Another, similar, Lifepak 1000 recall, was also issued in March 2017. The FDA indicated there had been dozens of reports of the defibrillators suddenly shutting down.
It is unclear whether the problems are related, however, Stryker announced they will be contacting customers directly with instructions on how to update the devices’ firmware that will prevent the lock-up condition. Stryker anticipates all devices subject to this field action will be serviced and corrected by December 2019.
Customers are being asked to contact Stryker for additional questions or concerns regarding the defibrillators at 1-800-442-1142. Adverse events involving the impacted devices should be reported to the FDA’s MedWatch Adverse Event Reporting Program.