According to the Food and Drug Administration, 561 deaths have been reported related to recalled Philips devices used to treat obstructive sleep apnea and other breathing disorders.
The FDA said it has received more than 116,000 medical device reports of foam collapse in Philips Continuous Positive Airway Pressure (CPAP) and BiPAP sleep therapy devices since April 2021. This includes 561 death reports, according to the agency said Wednesday.
The Dutch medical device maker has recalled millions of respirators because of reports that gas and foam particles were blowing into the airways of those who used the devices.
The polyester-based polyurethane foam used in noise and vibration reduction devices can break down and form black pieces of foam or invisible chemicals that can be inhaled or swallowed by the person using the device. “These problems could potentially result in serious injury and require medical intervention to prevent permanent injury,” the FDA said.
The grim results come days after Philips announced it submission.The company announced in a settlement with the FDA and the Justice Department that is expected to cost around $400 million
The tentative agreement, which must be approved by a U.S. court, requires the company to continue servicing existing apnea devices and stop selling new devices until certain conditions are met.
After onePhilips attempted to repair some of the more than 5 million recalled devices, but ultimately the repaired devices were also recalled.
Philips agreed at the end of 2023Users of 20 different breathing machines and ventilators sold in…