Stryker

Stryker Initiates Voluntary Field Correction for LIFEPAK Monitor/Defibrillator, Six Deaths in Ten Years

By MedTech Intelligence Staff
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Stryker

The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.

Today Stryker launched a voluntary field action on certain units of its LIFEPAK 15 Monitor/Defibrillators. Since 2009, the company has received 58 complaints globally about a lock up issue involving the device, which can result in serious injury and in six cases, led to death. “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,” Stryker stated in a news release, potentially delaying therapy.

The field correction includes a firmware update for a component of the device’s system printed circuit board assembly. Stryker has been contact customers who have the impacted device (an estimated 13,000 products) and expects all them to be serviced by December 31.

Despite the lock up issue, Stryker is still telling customers to use the device but to also perform daily checks of it. It also provided troubleshooting instructions should the lock up occur during patient use.

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