Stryker has launched a voluntary field action on specific units of the LIFEPAK 15 monitor and defibrillator.
In an announcement issued by the company on 27 December 2019, and subsequently via the US Food and Drug Administration (FDA) on 10 January 2020, Stryker has notified a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the ‘Shock’ button on the keypad is pressed.
According to the statement, the issue is a result of oxidation that may have formed over time within the button.
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.
The announcement noted that most complaints associated with this issue were detected prior to patient use. Routine testing of the device can detect this fault condition, Stryker added.
The company is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the Operating Instructions until the correction can be completed.
