Medical device company Stryker has launched voluntary field action for certain units of its LIFEPAK 15 monitors/defibrillators due to a problem that has spawned dozens of complaints, including six patient deaths, the company announced today.
Stryker is warning customers of an issue that might cause the device to lock up after a defibrillation shock is delivered. When the device locks up, the monitor display is blank with the LED lights on, which indicates power to the device, but there is no response in the keypad and device functions.
This issue can delay the delivery of therapy, which can result in serious injury or death.
In fact, since the product’s initial commercialization in 2009, there have been six events in which a patient died following a delay in therapy. And Stryker has been made aware of 58 complaints reported globally relating to the issue.
More than 13,000 devices can potentially be impacted by this and are within scope of the field action that Stryker initiated.
But Stryker is not telling customers to stop using the LIFEPAK 15 Monitor/Defibrillator.
The company is instructing customers to use the device according to the operating instructions until correction can be completed. Customers should perform the daily check from the operator’s checklist, specifically the QUIK-COMBO therapy cable check from the general maintenance and testing section.
If the device locks up during patient use, the provider should follow the steps from the general troubleshooting section of the instruction manual and turn the device off and then back on.
Founded in 1941, Stryker produces devices and services in the orthopedic, surgical and other medical spaces to help improve patient and hospital outcomes. Products include surgical visualization tools, ambulation and equipment managements and image-guided therapies.
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