The Stryker company is recalling thousands of defibrillators due to a malfunction of the device. The US FDA reported that Stryker’s LIFEPAK 15 device may lock up after delivering a defibrillation shock. The company said the malfunction may delay delivery of therapy, which can cause serious injury or death.
58 Complaints, 6 Deaths
Since 2009, nearly 60 complaints have been reported to the FDA over the Stryker device. At least six people have reportedly died from the machine’s malfunction. According to the FDA, Stryker is “instructing customers to continue to use their (device) according to the operating instructions until the correction can be completed.”
Stryker Recalls LIFEPAK 15 Defibrillator
Stryker itself said the six deaths appear to be related to the defibrillator’s lockup malfunction. The company said it has become aware that certain LIFEPAK 15 Monitor/Defibrillators have been 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, which indicates power to the device, but no corresponding response in the keypad and device functions.
Stryker is contacting people affected by the recall and pledging to fix the problem. The company says that if the device “exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10) of the (device) should be immediately followed.”
More than 13,000 devices are potentially impacted by the recall. Stryker is advising patients to continue using their LIFEPAK 15 devices as usual until the company can fix the problem.
Defibrillators are common throughout the civilized world. The paddle-fitted, electrical devices are used to shock and revive people whose hearts have suddenly stopped beating. The National Institutes of Health explains that these devices are meant to “restore a normal heartbeat by sending an electric pulse or shock to the heart. They are used to prevent or correct an arrhythmia, a heartbeat that is uneven, or that is too slow, or too fast. Defibrillators can also restore the heart’s beating if the heart suddenly stops.
Heart experts at Johns Hopkins claim that at least 522 lives can be saved yearly in the U.S. and Canada by the widespread placement of automated external defibrillators. There is general consensus in the medical community that defibrillators are helpful devices when they are properly designed and used, and are functioning properly.
- Dangerous Medical Devices Not Tested
- FDA Medical Device Proposal Threatens Public Safety
- Defibrillators Recalled by Stryker