Defective Medical Products Comments Off on FDA Warns about Defective Philips Defibrillators that May Fail in Emergency
The U.S. Food and Drug Administration (FDA) has issued a fresh warning to consumers about some models of HeartStart automated external defibrillators (AED) may not work during a cardiac emergency. According to a CBS news report, about 700,000 of the medical devices, manufactured by Philips Medical Systems, had been recalled in 2012, but people may still have the faulty models in their possession. The FDA is urging consumers to inspect and monitor the capabilities of these AEDs and also know how to use them during an emergency, particularly when there are no other available options.
The Philips AEDs first got FDA approval in 2004. The AEDs that are being recalled were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. These devices were recalled in 2012 because an internal electrical component was malfunctioning, causing the machine not to give a shock.
Why an AED is Life Saving
The federal safety agency is also advising that you keep the recalled HeartStart AEDs in service until you obtain a replacement from Philips or another AED manufacturer. The AED’s function is to analyze heart rhythm and deliver an electric shock, which can restart the heartbeat of those who go into cardiac arrest. In 2013 alone, about 359,400 people will have an out-of-hospital cardiac arrest, the American Heart Association estimates. If you still own one of these devices, contact Philips Healthcare for a replacement AED unit. In North America, call 1-800-263-3342 for more information.
Defective Medical Devices
When an AED fails to work as it is supposed to, it may become difficult or impossible to resuscitate someone whose heart has stopped functioning. Anyone who has been affected by a defective medical device can file a product liability claim against the manufacturer of the defective product. In cases where a person has died, his or her family can file a wrongful death claim against the product manufacturer. Victims or families of deceased victims would be well advised to contact an experienced product liability lawyer who will ensure that the negligent manufacturers are held liable. The best product defect law firms will always offer a free consultation and comprehensive case evaluation to injured victims and their families.