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Recall of Certain Sleep Apnea Air Flow Generators

Posted on April 29, 2008

The device company ResMed is recalling about 300,000 of the company's S8 flow generators. These devices treat patients with obstructive sleep apnea by providing continuous positive air pressure (CPAP).

The problem is that some of these devices have developed a short circuit in the power supply connector, causing the device to fail. In a few cases, the device overheated. If that happens, there is a possibility that material around the device could catch fire. The company says that there has been no significant property damage or patient injuries to date.

The recall affects all Model S8 devices manufactured between July 2004 and May 15, 2006. To identify these devices, check both the part number and the serial number, which are located on the name plate on the bottom of the device.

ResMed is providing patients with replacement devices. The company says that patients can continue to use their S8 flow generators until they get a replacement, except for those patients who require supplemental oxygen. These patients should not use oxygen with an affected device. Instead, they should immediately contact their home healthcare provider for a replacement.

As with any electrical device, patients should also make sure that their flow generators are placed on a hard clean surface, and that the area around the device is clear during use. They should stop using the device if there are any signs of electrical failure, such as intermittent power, crackling sounds, sparking or a charred smell. For more information contact the ResMed S8 Replacement Call Center at 888-899-8991.

Additional Information:

FDA MedWatch Safety Alert. ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP): S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage. April 24, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed

ResMed Website. Global Press Release.
http://www.resmed.com/en-us/s8program/s8program.html

ResMed Website. S8 Program – FAQ. May 15, 2007.
http://www.resmed.com/en-us/s8program/amr/english/faq.html

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