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MRL Issues Voluntary Worldwide Recall of Selected AED20 AEDs

May 12, 2005

MRL, a Welch Allyn company, announced it is initiating a voluntary worldwide recall of 597 AED20 automatic external defibrillators (AEDs) manufactured in Buffalo Grove, Ill. between February and July 2004.

The AED20 may display a "Defib Comm" error message on the device display during use, resulting in a failure of the device to analyze the patient's electrocardiogram and deliver the appropriate therapy, which prevents the defibrillator from resuscitating a patient. This problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield enabling an electrical short between the connector and the external housing of the AED20.

The company has received 12 related complaints with this specific group of AED20s, including one instance in which the short may have prevented patient resuscitation. MRL initiated a mailing May 5 to its customers who purchased AED20s in this group of devices (296 sold within the U.S. and 301 outside of the U.S.). The company is providing customers with a loaner AED20 at no cost while their unit is being serviced, and will pay all costs associated with shipping, handling and corrective service.