Phillips has recalled thousands of HeartStart Automatic External Defibrillators (AED) because they may fail to deliver a shock due to a defective electrical component. According to the Wall Street Journal, the FDA has received 1,100 complaints and nearly 600 adverse event reports associated with the HeartStart defibrillator.
UPDATE: Covidien Recalls Electrodes – May Not Work With HeartStart AED
October 14, 2014 — Covidien is recalling Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes because they may not work with Philips HeartStart FR3 and HeartStart FRx defibrillators. Click here to read more.
What is the HeartStart Defibrillator?
The HeartStart Defibrillator, also known as an automatic external defibrillator (AED). It is a battery-powered device that delivers an electric shock through pads placed on a patient’s chest to restore heart rhythm. It is used to treat people who experience sudden cardiac arrest or ventricular fibrillation, when the bottom chambers of the heart flutter ineffectively and fail to pump blood into the body and lungs.
What is the problem with HeartStart Defibrillator?
December 3, 2013 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn that thousands of HeartStart defibrillators manufactured by Phillips Healthcare may not work in an emergency. The problem is a defective electrical component that may fail to deliver a shock or mistakenly indicate that the defibrillator is ready to use.
HeartStart Linked to 580 Adverse Events
The Wall Street Journal reports that hundreds of adverse events have been linked to the HeartStart AED:
“The FDA has received 1,100 complaints regarding the devices and 580 adverse event reports, Ms. Rodriguez said in an email. She could not immediately say whether any deaths or injuries had been reported.”
HeartStart Defibrillator Recall
Phillips first issued a Class II recall of HeartStart defibrillators in September 2012. On November 19, 2013, Phillips sent a Maintenance Advisory and advised customers to immediately contact Phillips HealthCare for a replacement unit.
What HeartStart Defibrillators Were Recalled?
The recall involves three lines of HeartStart defibrillators manufactured by Phillips between 2005 and 2012. Approximately 700,00 units were sold worldwide.
Products included in HeartStart defibrillator recall:
- HeartStart FRx AED: Used by first-responders including fire departments and Emergency Medical Service (EMS).
- HeartStart HS1 Home: Used in the home.
- HeartStart HS1 OnSite: Used in public locations, including airports, schools, government buildings, community centers, etc.