Stryker Issues Field Action for Some LIFEPAK 15 Defibrillators

Patrice Wendling

January 13, 2020

Stryker is alerting customers that some of its LIFEPAK 15 monitor/defibrillators may fail to deliver a defibrillation shock after pressing the "shock" button because oxidation may have formed over time within the button.

"Most complaints associated with this issue were detected prior to patient use. Routine testing of the device can detect this fault condition," the company said in a notice published late last week by the US Food and Drug Administration.

Stryker is advising customers to continue using their device. They should also continue to perform the daily check as described in the operator's checklist and, specifically, the QUICK-COMBO therapy cable check as described in the general maintenance and testing section (page 10-4 and the LIFEPAK 15 monitor/defibrillator operator's checklist, number 7).

Stryker is contacting customers to schedule the correction of the devices, which will include replacement of the affected keypad. It is anticipated that all devices will be fixed by June 2021, the company says.

In February 2019, Stryker issued another field action for LIFEPAK 15 monitor/defibrillators related to the devices potentially locking up after a defibrillation shock is delivered.

Customers with questions regarding this new field notification can contact Stryker by calling 1-800-787-9537 (option 2) from 8:00 AM to 7:00 PM (EST) Monday through Friday, by sending an email to MedTechSup@stryker.com, or by sending a fax to 1-800-329-7879.

Adverse reactions or quality problems associated with LIFEPAK 15 defibrillators should be reported to FDA's MedWatch Adverse Event Reporting Program.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

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