May 13, 2005

FDA ALERT

MRL AED20 Automatic External Defibrillator recall due to failure to deliver shock

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

MRL Inc. and FDA notified healthcare professionals of a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured between February and July of 2004. The AED20 may display a "Defib Comm" error message during use resulting in a failure of the device to analyze the patient's ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. The company has received 12 related complaints with this specific group of AED20's, including one instance which may have prevented patient resuscitation.

Read the complete MedWatch 2005 Safety summary, including the link to the firm press release, at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#MRL