Feb. 5, 2019 — The maker of a portable defibrillator is warning customers that the device may lock up and freeze when used, a problem responsible for at least six deaths, the FDA says.
The Stryker company sells the LIFEPAK 15 Monitor/Defibrillators and reports that the it has received 58 complaints of devices freezing after delivering its electric shock. The FDA says Stryker is contacting customers who have devices and will fix each one. If you have this issue, contact Stryker at 800-442-1142 and select option “7.”
In each of the six cases that ended in a patient dying, the device delivered at least one shock before locking up. More than 13,000 of the devices are in homes and businesses around the world. The device’s own automatic self-diagnostic test will not catch the problem.
For more information, visit, http://www.strykeremergencycare.com/productnotices or email [email protected].
FDA.gov: “Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK 15 Monitor/Defibrillator.”
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Originally Published 2019-02-05 20:58:38