[Temslist] FW: Class 1 Recall: Welch Allyn AED 10 Automatic External Defibrillators manufactured between 3/29/07 and 8/9/07

[Tidewater EMS Council Listserv]

-----Original Message-----
From: MEDWATCH - The FDA Safety Information and Adverse Event Reporting
Program [mailto:MEDWATCH at LIST.NIH.GOV] On Behalf Of CDER MEDWATCH
LISTSERV
Sent: Monday, November 05, 2007 1:42 PM
To: MEDWATCH at LIST.NIH.GOV
Subject: 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