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.
The
safety communication includes recommendations to better inspect and
monitor the readiness of these devices, as well as steps to follow if
someone must use a recalled device in an emergency situation.
“If
the device indicates it has detected an error during a self-test the
FDA advises users to keep recalled HeartStart AEDs in service until a
replacement from Philips Healthcare or another AED manufacturer is
obtained,” said Steve Silverman, director of the Office of Compliance in
the FDA’s Center for Devices and Radiological Health. “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.”
These
devices were manufactured and distributed between 2005 and 2012 under
the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1
OnSite. Users of the recalled devices, who may include consumers and
first responders, should contact Philips Healthcare 
for more information.
An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
for more information.An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
In
September 2012, Philips Healthcare initiated the recall of HeartStart
FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the
failure of an internal electrical component. The recall affected
approximately 700,000 devices. In a Medical Device Safety Notice dated
November 19, 2013, Philips provided consumers with updated information
about the failure of an internal electrical component that could cause
the AEDs to fail to deliver a shock.
The
FDA will continue to closely monitor all AED manufacturers’ quality
system practices and manufacturing changes that have persistently
contributed to recall and adverse events associated with AEDs.
In
March 2013, the FDA issued a proposed order that if finalized would
require manufacturers of AEDs and accessories to submit premarket
approval applications that focus specifically on the critical
requirements necessary to assure AEDs are safe and effective. The main
objective of this proposed regulatory approach is to improve the
reliability of AEDs so that they can continue to save lives.
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm377433.htm
