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Product notices

GDR 3344496_A    07/2020

Infant/Child electrodes

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The artwork on the defibrillation electrodes, as manufactured by Cardinal Health, does not meet Physio-Control’s specifications, and shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. The artwork on the electrode packaging shows the correct electrode placement for an infant.

LIFEPAK 500

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Stryker has become aware that LIFEPAK 500 AEDs in high-use environments (Emergency Medical Services) may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. 

LIFEPAK 15 Lock-up Condition

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Stryker has become aware that certain LIFEPAK 15 Monitor/Defibrillators were reported to experience a lock-up condition after a defibrillation shock was delivered. This 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.

 

Verification of impacted device(s) status

Please call Stryker Customer Support at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (Pacific), Monday – Friday to provide verification of the status of your device(s).

LIFEPAK 20e defibrillator/monitor

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Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off.