Thursday, April 2, 2020

Thursday, April 2, 2020

FDA issues safety alert regarding wearable defibrillator; two deaths attributed to software defect


Safety concerns have led to a government warning about a wearable defibrillator.

The U.S. Food and Drug Administration on March 6 issued a bulletin regarding the Zoll LifeVest 4000, which adults and children at risk for sudden cardiac arrest wear to guard against abnormal heartbeats. The only such device available in the U.S., the LifeVest 4000 is designed to continuously monitor heart rate and, if it detects an abnormality, deliver an electrical shock to restore regular heart activity.

According to the FDA, people who use these vests should be on guard for an error message that reads “Call for Service—Message Code 102.” LifeVest products displaying that text should be replaced immediately, as it indicates the vest might fail to deliver an electrical shock to its wearer if needed. The FDA said two deaths were attributable to this defect.

Vest owners who have seen the error message should call Zoll immediately at 800-543-3267 to request a replacement, according to the FDA.

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US Food and Drug Administration

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