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U.S. Department of Health and Human Services

Medical Devices

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Welch Allyn Co., AED 20®, Automatic External Defibrillator

Class 1 Recall
Date Recall Initiated:

April 28, 2005

Product:

Welch Allyn AED 20®, Automatic External Defibrillator, part number 972200E. A total of 597 were manufactured between February and July 2004 which are subject to the recall.

Use:

Automatic external defibrillators are intended to be used for the treatment of cardiac arrest. The defibrillators are intended to deliver a shock to the heart to restore normal heart rhythm. Prior to delivering the shock, the device analyzes the patient’s heart rhythm to determine if a shock is appropriate.

Recalling Firm:

MRL Inc., a Welch Allyn Company
1000 Asbury Drive
Suite 17
Buffalo Grove, IL 60089-4551

Reason for Recall:

The affected AED is susceptible to malfunction which may in some cases prevent the AED from delivering a shock and thus, result in a delay in treatment or death of a viable patient. This recall was initiated after receipt of a complaint of malfunction during clinical use that resulted in a death in Canada . The malfunction occurs when impact to the exterior of the AED20 causes an internal electrical short resulting in the AED20 failing to analyze the patient’s heart function. When this malfunction occurs during clinical use, the AED20 displays a “Defib Comm” error message on the device display.

Public Contact:

Consumers with questions may contact the company at 1-847-520-0300, Ext. 153.

FDA District:

Chicago

FDA Comment:

Distributors of these AEDs were notified of this recall on 4/28/2005 . Urgent recall letters were sent to direct account customers on 5/5/2005 and the company issued a press release on 5/10/2005 . 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.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

For additional information on this product recall, see the nearby links.