The U.S. Food and Drug Administration (FDA) has issued a recall of automated external defibrillators after learning that they may fail to deliver a shock in the event of an emergency. This recall includes devices that are used by first responders (such as EMS personnel) as well as devices that are used by individuals in the home as well as large public places likes schools and airports. The FDA has recalled the Philips HeartStart FRx AED, the Philips HeartStart HS1 Home AED, and the Philips HeartStart HS1 OnSite AED.
Automated external defibrillators are medical devices that analyze the heart’s rhythm. In the event of a cardiac arrest, the defibrillator delivers an electrical shock to help the heart re-establish an effective rhythm. A sudden cardiac arrest can affect over 350,000 people each year and the AED is the only effective treatment for restoring a regular heart rhythm.
It is difficult for the FDA to know exactly how many injuries or deaths have been affected by an AED malfunction because the patients who need the devices are in a life threatening situation to begin with. Because of the emergency situations that the AEDs are designed for, the FDA recommends that people who have the recalled devices continue to keep the devices in their possession until they can obtain a new one or the recalled device is replaced by Philips Healthcare.
The FDA is continuing to closely monitor the quality of the systems and the status of the recall. It is believed that over 700,000 AED units are affected by the recall.