Healthcare equipment company Stryker Corp. launched a voluntary field action for certain units of LIFEPAK 15, a monitor and a defibrillator device.
LIFEPAK 15 is an acute cardiac care response system designed for basic and advanced life support situations where the patient is experiencing certain potentially fatal arrhythmias, an irregular heartbeat.
In a U.S. Food and Drug Administration's safety report on Jan. 10, Stryker notified LIFEPAK 15 customers that certain devices might fail to deliver a defibrillation shock after the "Shock" button on the keypad is pressed. The company identified the problem might be due to oxidation formed over time within the button.
The company said the issue can be fixed by replacing the keypad and expects all affected devices will be serviced by June 2021.
Stryker noted that most complaints regarding the issue were detected before patient use, as routine testing of the device can uncover the problem. The company instructed customers to continue using the device according to the operating instruction until their device is serviced.