Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs) are being recalled because they have a software defect that may cancel shock during the charging process. This problem can cause a delay in therapy, which may result in failure to resuscitate the patient. The recall is classified as a Class 1, the most serious type of recall the Food and Drug Administration (FDA) can issue and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

AEDs are life-saving devices that send a jolt of electric current to the heart of people who are unconscious and suffering from cardiac arrest in order to restore a normal heart rhythm. However, the devices have been plagued by defects over the years, which have caused serious injuries and deaths, and spurred a series of recalls.

Between January 2005 and May 2010, the FDA received more than 28,000 adverse event reports for various brands of AEDs. In 2009 alone, the FDA issued 17 recalls on the devices for problems ranging from confusing instructions to wiring problems to memory chip defects.

Last fall, the federal agency asked AED manufacturers to meet together in an effort to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices. Results of that meeting have yet to be posted.

The latest AED recall includes Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. Customers with the recalled devices should contact the manufacturer for a free software upgrade. Customers are asked to keep their AED in service during the software upgrade process.

Any serious side effects caused by AEDs or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

Sources:
Beasley Allen Southern Injury Lawyer
FDA