ResMed announces massive recall

Thursday, May 31, 2007

SAN DIEGO - ResMed announced in late April a worldwide voluntary recall of approximately 300,000 of its early production S8 CPAP units.
In S8 devices manufactured between July 2004 and May 15, 2006, a remote potential exists for a short circuit in the power supply connector, ResMed reported in a press release.
ResMed voluntarily recalled the product after learning that in 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 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, the company stated.
Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or a charred smell.
Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement, ResMed stated.