Philips Healthcare HeartStart Defibrillator Lawsuits are currently being investigated on behalf of individuals who were severely injured or died after being treated with the devices. On December 3, 2013, the U.S. Food & Drug Administration (FDA) warned that thousands of defibrillators made by Philips Healthcare may not work correctly during medical emergencies because of an electrical component failure. According to the Wall Street Journal, the FDA has received approximately 1,100 complaints and 580 adverse event reports associated with the Philips Healthcare HeartStart Defibrillator.
Free Lawsuit Evaluation: If you or a loved one has been injured by a Philips Healthcare HeartStart Defibrillator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the Philips Healthcare HeartStart Defibrillator and we can help.
What’s the Problem with the Philips Healthcare HeartStart Defibrillator?
The Philips Healthcare HeartStart Automated External Defibrillator (AED) is designed to help save the lives of cardiac arrest patients by analyzing heart rhythms and delivering an electrical shock to restore the natural pace of the heart. However, it has recently been found that certain Phillips HeartStart AEDs may be unable to deliver the required defibrillator shock in emergency situations. These defibrillators were distributed from 2005 to 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.
Philips Defibrillator Recall
In September 2012, Philips Healthcare announced a nationwide recall for the above-listed defibrillators due to the failure of an internal electrical component. According to the FDA, the recall affected about 700,000 products. In a Medical Device Safety Notice issued November 19, 2013, the company provided updated information about the failure of an internal electrical component that could cause the defibrillators to fail to deliver a shock.
In March 2013, the FDA issued a proposed order that would require AED manufacturers to submit premarket approval applications that focus specifically on the requirements necessary to ensure their products are safe and effective to use as directed. The objective of the proposed order is to improve the reliability of automated defibrillators so they can continue to save lives.
In an emailed statement issued December 3, Philips quoted several figures that differed from the FDA’s. The company stated that just 605,000 AEDs are affected by the recall worldwide, and that 284,000 (approximately 47%) are in use in the United States.
Mario Fante, a Philips spokesman, said that 88% of customers had been contacted about the problem with the defibrillators, and that it “continues to trace customers who have moved or whose addresses are no longer valid.” The company has not received any reports of patient harm due to the electrical issue in the eight years the AEDs have been on the market, Mr. Fante said.
FDA Recommendation on Phillips AEDs
The FDA is recommending that all owners of Philips HeartStart Defibrillators contact the company for support. Consumers should keep the recalled devices in service until Philips replaces them, or they can obtain another working defibrillator. If you are unsure whether your Philips HeartStart AED is affected by this recall, please contact the company for additional information.
Please Note: Philips HeartStart AEDs are designed to automatically test themselves regularly to ensure they are ready for use. The devices should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent it from working properly.
Do I Have a Philips Healthcare HeartStart Defibrillator Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Philips Healthcare HeartStart Defibrillator Lawsuits. We are handling individual litigation nationwide and currently accepting new Philips Healthcare HeartStart Defibrillator injury and death cases in all 50 states.
Free Philips Healthcare Defibrillator Lawsuit Evaluation: If you or a loved one has been injured by a Philips Healthcare HeartStart Defibrillator, you should contact our law firm immediately. You may be entitled to compensation by filing a Philips Healthcare HeartStart Defibrillator Suit and we can help.