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U.S. Department of Health and Human Services

Medical Devices

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Laerdal Medical Corp. CM 100 Heartstart® Automatic External Defibrillator Adapter Cables

Class 1 Recall
Date Recall
Initiated:

April 29, 2005

Product:

CM 100 Heartstart® Adapter Cable, Cat. No. 920650, all lots. Over 3,000 Adapter Cables were distributed in the U.S. since 1996. The adapter cables are sold in a clear plastic bag with a white stick on label that reads “PART # 920650 ADAPTER CM100/LMC ELECTRODE”. The products can also be identified by the number 281-132-00 displayed on a white label affixed to one of the cable leads.

Use:

The adapter cable allows the use of the Laerdal Heartstart multifunction defibrillator pads to be used with the Heartstart 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. 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:

Laerdal Medical
167 Myers Corner Rd
P.O. Box 1840
Wappingers Fall, NY 12590-8840

Reason for Recall:

The affected AED adapter cables are susceptible to breakage which may, in some cases, prevent the AED delivering a shock, which could result in a delay in treatment or death of a viable patient. This recall was initiated after receipt of several user complaints of malfunction during clinical use that resulted in deaths in the U.S.

Public Contact:

Consumers with questions may contact the company’s recall contractor at 1-800-668-4391. Other inquiries should be addressed to Laerdal at 1-877-523-7325.

FDA District:

New York Upstate

FDA Comment:

Laerdal Medical Corp issued a press release on 4/28/2005 and letter notification to end user customers on 4/29/2005. The letters were flagged: ‘URGENT RECALL NOTIFICATION’. Customers are instructed to discontinue use of the Adapter Cables and to order alternative cabled electrodes that do not require adapters from Philips Medical Systems.

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.