Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) and medical diagnostic equipment manufacturer Welch Allyn have issued a notice to health care professionals and consumers of a voluntary worldwide Class 1 Recall on more than 14,000 of its AED 10 Automatic External Defibrillator (AED) and the MRL JumpStart AED.

A Class 1 Recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

AEDs are devices used to emergency or medical personnel or by others who have completed CPR AED training courses. It is intended to treat adults in a heart attack (cardiac arrest). The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electric shock to the heart if needed to restore a normal heart rhythm.

The recall was issued because the devices may experience low defibrillation energy delivery, unexpected device shutdown, and/or inadequate filtering of electromagnetic noise. These issues could lead to a sudden stoppage of the device, may prevent defibrillation of a patient in cardiac arrest, which could lead to death.

The AEDs included in the recall were manufactured from October 3, 200 through January 25, 2007, a full listing of serial numbers, please refer to the company’s press release here.

Customers who have the recalled devices should contact Welch Allyn at 1-888-345-5356 between 8 a.m. and 5 p.m. Eastern Standard Time. Customers may also visit the company’s recall website at www.welchallyn.com/AED10Recall for more information or to learn if their unit is subject to this recall.

This entry was posted on Wednesday, March 18th, 2009 at 8:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.