FDA ALERT

 

November 06, 2007

FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators manufactured between 3/29/07 and 8/9/07 - Class 1 Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.

Read the complete MedWatch 2007 Safety Summary including a link to the Class 1 Recall Notice, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#aed10

 

September 18, 2007

FDA MedWatch: MRL/Welch Allyn AED 20 Automatic External Defibrillators Class I Recall Due To Error Message On Device Display

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.

Read the complete MedWatch 2007 Safety Summary including a link to the FDA recall notice at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#mrl