FDA safety communication advises of potential malfunction in Philips defibrillators
December 09, 2013
The U.S. Food and Drug Administration has issued a new safety communication for previously recalled HeartStart automated external defibrillator devices, advising that some of the AEDs may be unable to properly perform in cardiac emergencies.
Philips Healthcare initiated a Voluntary Medical Device Recall of approximately 700,000 HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs in September 2012. The recall came after a determination that an internal electrical component in the AEDs could fail and the devices could incorrectly indicate readiness for use.
Philips Healthcare also issued a Medical Device Safety Notice dated Nov. 19, 2013, providing customers with updated information about the failure of an electrical component that could cause the AEDs to fail to deliver appropriate shock.
Dr. Don Cohen, chief compliance officer of HealthFirst, which supplies emergency response and other compliance products to dental offices, said dental practices should note that proper functioning of AEDs is not just a matter of safety, but also one of compliance.
“Remember, an inoperable AED puts you at risk of being unable to respond to a cardiac crisis and also could lead to non-compliance with your state licensing board's requirements,” Dr. Cohen said. “From a compliance perspective, it is important to note that many states require all dental practices to have a working AED on site. A number of other states also require any practice using conscious or IV sedation to have AEDs as well. As a matter of best practice, we at HealthFirst believe that every dental office, regardless of the level of sedation used, should maintain a working AED, because dental practitioners have a responsibility as health care providers to properly respond to medical emergencies, which can and do occur in dental offices.”
AED users, who may also include first responders and consumers, should contact Philips Healthcare to inquire about replacement units for HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite—AEDs manufactured and distributed between 2005 and 2012, which could potentially fail to deliver a shock in a cardiac emergency. Users may contact Philips Healthcare at 1-800-263-3342.
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. The Philips HeartStart AEDs should automatically test themselves at regular intervals to ensure readiness for use. The devices should emit a triple-chirp sound if a serious problem is detected that could prevent the HeartStart AED from delivering an electrical shock.
“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.”
The FDA safety communication for HeartStart AEDs is available online.
Users who suspect that an AED has malfunctioned can file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. The reports help the FDA identify and better understand the risks associated with medical devices.
Call the FDA at 888.INFO.FDA with consumer inquiries related to the HeartStart AED safety communication.