Cardiac arrest. CPR in progress. Do not use the AED, because it has been recalled!
HeartStart automated external defibrillators from Philips Healthcare have been recalled.
What does the FDA (Food and Drug Administration) mean by recall?
Well, why was the recall issued?
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
A shock might not be delivered.
What does the FDA recommend?
“The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.
Do not take these AEDs out of service service until a replacement is present.
What about the lawyers?
But it’s defective!
Thinking is dangerous!
“Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
The benefit is greater than the risk.
There is risk with everything.
Anyone who tells you otherwise is selling something.
There is not benefit with everything.
Since the detection of an error during the self-test does not guarantee that the AED will not deliver a shock when needed, removing the AED without a replacement is more dangerous than leaving the AED in service.
These recalled AEDs are better than no AED.
Of course, if needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the Owner’s Manual.
The manufacturer and the FDA agree that, in the case of these AEDs, something is better than nothing.
Are we really going to make a dead patient more dead by using a defective AED?
 FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
FDA News Release
For Immediate Release: Dec. 3, 2013
Media Inquiries: Jennifer Rodriguez, 301-796-8232, email@example.com
Consumer Inquiries: 888-INFO-FDA