ResMed Recalling 300,000 CPAP Devices for Short-Circuit
Poway, Calif.-based ResMed is recalling about 300,000 S8 flow generators, which are Continuous Positive Air Pressure devices, worldwide that are used to treat obstructive sleep apnea. S8 devices manufactured between July 2004 and May 15, 2006, have the "remote" potential for a short-circuit in the power supply connector, the company said yesterday. The U.S. Food and Drug Administration posted a notice and press release on its MedWatch site.
ResMed is working with its distribution partners to provide replacement devices to affected patients, according to the notice, which said patients may continue to use their S8 flow generators until they receive a replacement device but should not use supplemental oxygen with an affected device. "[P]atients using supplemental oxygen should immediately contact their home healthcare provider for a replacement," it said.
ResMed said it voluntarily recalled the product "after learning that in rare instances — less than two tenths of one percent (0.2%) — a short circuit in the power supply connector, a component supplied by a third party, has caused the devices to fail. In only seven cases worldwide, device failures have led to thermal damage to the device, with a remote potential to ignite material external to the device. No significant property damage or patient injury has been reported." It asked patients to call 888-899-8991 or visit www.resmed.com/en-us/s8program/s8program.html for more information.