On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that may lock-up after a defibrillation shock is delivered.”
The recall notice states that the issue is limited to LIFEPAK 15 Monitor/Defibrillator devices with certain System Printed Circuit Board Assemblies, and that 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. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.
Stryker states that since the initial commercialization of LIFEPAK 15 in 2009, it has become aware of 58 complaints reported globally for this issue, including 6 events in which the patient died following a delay in therapy. In all six of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition. There are 13,003 devices potentially affected by this issue and within scope of the recall.
Stryker warns that the device automatic self-tests do not identify this fault, as it occurs during defibrillation. Stryker states that 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), and that customers continue to use their LIFEPAK 15 Monitor/Defibrillator according to the Operating Instructions until the correction can be completed.
Stryker instructs that if a device exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10-18) of the LIFEPAK 15 Monitor/Defibrillator Operating Instructions should be followed:
1. Press and hold ON until the LED turns off (~5 seconds). Then press ON to turn the device back on.
2. If the device does not turn off, remove both batteries and disconnect the device from the power adapter, if applicable. Then reinsert batteries and/or, reconnect the power adapter, and press ON to turn the device back on.
LIFEPAK 15 Monitor/Defibrillator
Stryker describes its LIFEPAK 15 on its website as follows:
LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.
INTENDED USE: LIFEPAK 15 intended for use by trained medical personnel out-of-doors, in indoor emergency care settings, and is designed to be used for ground transportation. Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation (AED) mode intended for use on patients ≥8 years of age.
INDICATIONS FOR USE – MANUAL DEFIBRILLATION: Indicated for termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia.
CONTRAINDICATIONS – MANUAL DEFIBRILLATION: Contraindicated in treatment of PEA and asystole.
AED MODE: To be used only on patients in cardiopulmonary arrest. Patient must be unconscious, pulseless, and not breathing normally before using defibrillator to analyze patient’s ECG rhythm. In AED mode, the LIFEPAK 15 is intended for use on pediatric patients ≥ 8 years of age.
CONTRAINDICATIONS – AED MODE: None known.
If you or a loved one suffered harm due to a defective medical device or defibrillator in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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