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Recall on Welch Allyn PIC 50 Automated External Defibrillators

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This is the kind of news that strikes fear into people who want to be proactive about the safety of their environment, whether it be an airport, convention center, business or their own home. You expect that these Automated External Defibrillators to work without maintenance -- when you stick the pads on someone who's heart has stopped, you expect it to provide a shock, if the person's in ventricular tachycardia, not to display "various error messages on the display panel, including the "Defib Comm" error message." The breadth of time period is pretty suprising as well, 2 1/2 years of manufactured AEDs, "manufactured from March 2002 through October 2004."

I wonder if this will give consumers pause as to the reliability of all AEDs or if they'll treat this as an isolated event. Probably not even the latter, as few folks hear about these MedWatch recalls. Another concern I have is that I received this email a month after the initial report of concerns of a related product on 6/12/06, which I didn't notice: "a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient’s ECG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death."

Here's the current recall notice:


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Welch Allyn PIC 50 Automated External Defibrillators
Audience: Emergency services personnel and risk managers

MRL, Inc., and FDA notified healthcare professionals of a Class I recall
of Welch Allyn PIC 50 Automated External Defibrillators, catalog #97108X
manufactured from March 2002 through October 2004. An electrical
contact problem may result in the device's failure to provide a
defibrillation shock, that could result in delay or failure to
resuscitate the patient. This failure may be accompanied by various
error messages on the display panel, including the "Defib Comm" error
message.

Read the complete MedWatch Safety summary, including links to the FDA
Recall Notice and previous MedWatch alert


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About the Author


MD, FACP, FASN

Dr. Schwimmer's blog explores the intersection of medicine, new technologies, and the Internet.

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