Beaverton, Ore.
Protocol, Inc., a Welch Allyn Company, today announced it is initiating a voluntary worldwide recall of 1,722 MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005 at the former MRL, Inc. facility in Buffalo Grove, IL. A select group of MRL/Welch Allyn AED 20 devices, serial numbers 205787 through 207509, may experience failure or unacceptable delay in analyzing the patient's ECG and may not deliver appropriate therapy, which could possibly result in failure to resuscitate the patient. This will occur in combination with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED." This problem occurs because of an intermittent electrical connection within the device. This problem was identified in a previous recall issued in June 2006 that affected a different group of devices.
Owners of this defibrillator should contact their local Welch Allyn representative to obtain a loaner AED 20 at no cost while their unit is being serviced. Welch Allyn will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices. It is important to note that your AED 20 should be checked before each shift by using the self-test, which is automatically initiated by powering up the device. If a "Defib Comm" error message is displayed, or has been previously displayed, the device should be removed from service, if possible, and you should contact us to obtain priority servicing of one or more of your devices and a loaner. If the "Defib Comm" error occurs during use, cycling the power off-on may clear the error. Even if power cycling clears the device, you should contact us to obtain priority servicing of your AED20.
The company has received 21 related complaints about devices in this group of MRL/Welch Allyn AED 20's, corresponding to 1.2 percent of the 1,722 recalled devices which the company deems an unacceptable risk. Welch Allyn is taking preventative corrective action to update this select group of AED 20 devices. No other devices besides those manufactured between the above dates are subject to this recall. Welch Allyn will initiate notification via certified mail to its customers who purchased AED20's in this group of devices-932 of which were sold within the US and 793 outside the US.
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). Customers with questions may contact Welch Allyn Technical Support at 1-800-462-0777 for more information. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
About Welch Allyn
Founded in 1915 and headquartered in Skaneateles Falls, New York (USA), Welch Allyn is a leading global manufacturer of medical diagnostic equipment and a complete range of digital and connected solutions. With over 2,300 employees working in 17 different countries, Welch Allyn specializes in helping doctors, nurses, and other frontline practitioners across the globe provide the best patient care by developing innovative products, breakthrough technologies, and cutting-edge solutions that help them see more patients, detect more conditions, and improve more lives. More information about Welch Allyn and its complete line of connected products and solutions may be found at www.welchallyn.com.
