Defibtech AED Recall Issued Due to Charging and Humidity Problems
Nearly 66,000 LifeLine and ReviveR semi-automated external defibrillators (AEDs) sold in the United States have been recalled because they may cancel a charge while preparing to give a potentially life-saving jolt, or they may fail to properly charge in humid environments.
The defibrillator recall was announced on April 29 by the FDA after the manufacturer, Defibtech, LLC, alerted the agency and customers to the potential problem and decided to withdraw the defibrillators.
The FDA has classified the market withdrawal as a Class I medical device recall, meaning that the agency believes that the AED defect could cause serious injury or death.
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According to Defibtech, there are two conditions causing the units to fail. In some cases, the AEDs may unexpectedly cancel a charge while preparing to deliver a shock. However, in addition, about 11 percent of the units with that problem will also cancel a charge if they are in conditions of greater than 95% relative humidity or condensing conditions.
The recall affects the DDU-100 series of semi-automatic external defibrillators sold under the LifeLine AED and ReviveR AED labels. The units were sold worldwide, with 65,885 units distributed in the U.S. The recall only affects those units sold with 2.004 software or earlier.
In January, the FDA began considering more stringent manufacturing standards for all external defibrillators due to the high rate of recalls and failures.
From January 1, 2005 to July 10, 2010 the FDA received more than 28,000 medical device reports on problems with defibrillators, including malfunctions that led to patient deaths
According to the FDA, there were 68 external defibrillator recalls during the same time period, with the number of recalls growing each year. In 2005, there were nine recalls, but in 2009 there were 17. During the same time period, the FDA received more than 28,000 MDRs of defibrillator problems. That number, too, increased over the years from 4,210 reports in 2005 to 7,807 reports last year.
In November, the FDA sent a letter to medical device manufacturers warning them that if they could face stricter regulation of external defibrillators if they did not take action to address the recurring problems.
Last year saw a number of major defibrillator recalls and other defibrillator developments. In February, Cardiac Sciences recalled about 12,200 automated external defibrillators (AEDs) because the units could fail when needed. That recall was later expanded to 280,000 units when the FDA warned that the defective components were widespread throughout the company’s products.
Defibtech also recalled 5,400 rechargeable defibrillator battery packs in June due to defects that could prevent them from providing power.
Medtronic’s Physio-Control Inc. subsidiary has had to make two major recalls of LIFEPAK defibrillators. In April a recall of the LIFEPAK 15 defibrillators was announced because the units could turn off and on by themselves. In July about 43,000 LIFEPAK 20 and LIFEPAK 20e units were recalled due to possible power failures.
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