FDA issues safety alert on defibrillator

AHA News Now

LIFEPAK 1000 defibrillators may not be able to deliver therapy during a resuscitation attempt due to an intermittent connection between the battery and device electrical contacts, according to a safety alert issued Saturday by the Food and Drug Administration. Device maker Physio-Control has received 34 reports of the problem, including eight related adverse events. The company is contacting customers and advising them to immediately remove and reinstall the battery from the device, and implement a weekly schedule of battery removal and reinstallation. FDA encourages health care professionals and patients to report related adverse events or side effects to the FDA's MedWatch program. 

Topic: Advocacy and Public Policy
Tags: safety, regulation

Keyword Search

Date