Certain Lifeline and ReviveR AEDs Recalled

Shelley Wood

Disclosures

May 05, 2011

May 4, 2011 (Guilford, Connecticut) — Automatic external defibrillator (AED) manufacturer Defibtech has initiated a worldwide voluntary recall of some of its Lifeline AED and ReviveR AED devices in its DDU-100 series. The FDA has designated the recall as "class I" [1].

According to the company, two rare "conditions" could cause the AED to cancel shock during its recharging process, such that the device would not deliver its intended shock. One condition entails the AED actually canceling the charge--a risk the company puts at a one chance in 400 000 per month. The second "condition" also entails a canceled shock, occurring in high humidity situations and only in devices also affected by the first condition. "The only reported cases were in environments of greater than 95% relative humidity or condensing conditions," an FDA press release notes. The odds of an affected AED behaving in this matter are less than one in 250 000 per month.

Only DDU-100 series devices with 2.004 software or earlier are subject to the recall, the company notes.

For now, the company is advising that customers keep their AEDs in service until they perform the software upgrade, which the company is providing to customers free of charge to address the issue. The software upgrade can be done at the site where the AED is in use. The company has provided a website link for customers to help them find the serial number on the device and to check whether it is one of the recalled AEDs.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

An FDA notice reminds users that adverse reactions or quality problems seen with these AEDs should also be reported to the FDA's MedWatch program by phone at 1-800- FDA-1088, by fax at 1-800-FDA-0178, online, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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