FDA Warns of Problems with Recalled Phillips HeartStart Defibrillators

Government safety officials indicate that roughly 700,000 recalled HeartStart automated external defibrillators (AED) may be defective and fail to deliver a life-saving shock in the event of an emergency.  

A safety communication was issued by the FDA about a Philips HeartStart defibrillator recall on December 3, even though the devices were removed from the market more than a year ago.

The defibrillators were initially recalled because of an internal electric component that may fail and incorrectly indicate the device is ready to use, posing a delay in shock treatment. But the manufacturer has issued a recent warning that the devices may also not deliver the appropriate shock when needed. Although no injuries or deaths have been associated with the delays, this could pose a serious risk in case of emergency.

The HeartStart AEDs analyze the heart’s rhythm in victims going into sudden cardiac arrest, which allows the device to deliver the appropriate electrical shock to restore normal heart rhythm in emergency situations. The devices are used by medical emergency first responders typically in public areas such as airports, schools, community centers, and government buildings.

The affected devices were initially recalled by Philips Healthcare in September 2012, when they issued a Voluntary Medical Device Recall for the three AEDs after recognizing the potential electrical component issue. Following the notice, the FDA classified the device recall a Class II recall, indicating the chances of serious adverse health consequences or death due to device failure were remote.

At the time of the initial recall, the FDA considered the benefit of attempting to use the AEDs in cardiac emergency circumstances a greater benefit than the risk of not attempting to use the external defibrillator at all.

On November 19, Phillips issued a new maintenance advisory, giving updated information about an electrical component that could cause the device to fail to give the appropriate shock, resulting in the FDA safety communication this week.

The devices are designed to test themselves regularly to ensure they are ready for use but users should be cautious of a triple chirp sound and a flashing “i-button” as this indicates the machine has a serious problem and could prevent the machine from administering a shock.

The potentially affected products included in the warning notice are the Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite automated external defibrillators manufactured between 2005 and 2012.

In light of that announcement, the FDA reevaluated the risk of harm and sent updated information about the possible electric component failure to consumers with maintenance instructions. According to the agency, the chance of serious adverse health consequences or death directly related to the device malfunctioning is very difficult to conclusively determine.

The latest warning notice is advising owners of the affected Philips HeartStart AEDs to contact Philips Healthcare immediately at 1-800-263-3342 and select option 5 to forward the call to an operator for technical support. The warning notice advises all AED customers to keep the recalled devices until Philips replaces the product or until another form of AED is purchased.