Stryker has launched a voluntary field action on specific units of the LifePak 15 monitors/defibrillators. Specifically, the company is notifying 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. This is a result of oxidation that may have formed over time within the “Shock” 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. Most complaints associated with this issue were detected prior to patient use. Routine testing of the device can detect this fault condition. If a customer experiences this issue, they should contact Stryker as soon as possible at 800-787-9537 and select option 2.
Moreover, Stryker is instructing customers to continue to use their LifePak 15 monitor/defibrillator according to the Operating Instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK-COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LifePak 15 monitor/defibrillator Operator’s Checklist, number 7), Stryker officials say.
Information about this notice is available at: http://www.strykeremergencycare.com/productnotices. Impacted customers will be notified by letter and will be requested to verify their device status. Customers with questions regarding this notification, please contact Stryker by calling 800-787-9537, option 2, 8 a.m. to 7 p.m. (EST), Monday-Friday, or by email to MedTechSup@stryker.com or 1-800-329-7879.
In addition to contacting Stryker, any potential quality problems or adverse reactions or events associated with the use of a product from Stryker may be reported online to FDA’s MedWatch Safety Information and Adverse Event Reporting Program at https://www.fda.gov/safety/medwatch/, by phone 800-332-1088 or fax 800-FDA-0178.