Medtronic Expands Recall Lifepak 500 AEDs

April 26, 2005 — The U.S. Food and Drug Administration (FDA) and Medtronic, Inc., have notified customers via letter of the expansion of a class 1 recall of 1.924 monophasic LIFEPAK 500 automated external defibrillators (AEDs) to include 396 additional devices in use worldwide, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system.
The recall includes only devices manufactured in 1997 and does not affect other LIFEPAK products.
The original recall was issued on Feb. 28 due to 54 incident reports of AEDs continuing to display a "connect electrodes" message after electrode connection and failing to analyze the patient's heart rhythm. In eight instances, this malfunction may have prevented patient defibrillation/resuscitation.
According to the letter, all of the affected AEDs identified in the original recall have been updated or upgraded. The company plans to complete this process for the additional devices by May 31 and will be contacting owners worldwide with recommendations for use and replacement schedules.
Further information regarding the recall may be obtained by calling Medtronic Emergency Response Systems, Inc., at 1-877-873-7630 or by visiting the company's Web site at http://www.medtronic-ers.com/500 to determine if a particular device is included in the action.
AEDs are used to treat cardiac arrest by delivering a shock to the heart, thereby restoring normal cardiac rhythm. Prior to shock administration, the device analyzes the patient's heart rhythm to determine if a shock is appropriate. The defibrillators are often used by first responders, such as firefighters, police, and others trained in cardiopulmonary resuscitation.
Adverse events related to the use of LIFEPAK 500 AEDs should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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