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ROCKVILLE, Md. -- Some 300,000 home continuous positive airway pressure devices have been recalled by ResMed after short circuits from faulty wiring in electrical plugs, reported the FDA.
ROCKVILLE, Md., April 26 -- Some 300,000 home continuous positive airway pressure devices have been recalled by ResMed after short circuits from faulty wiring in electrical plugs, reported the FDA.
No patients were injured as a result of the defect in seven CPAP devices, which led to "thermal damage" that was not significant, the agency said.
The company said that patients who use supplemental oxygen should immediately discontinue use of the affected S8 flow generators because the wiring problem posed a fire hazard.
Likewise patients should immediately discontinue devices that show signs of electrical malfunction such as intermittent power, crackling sounds, sparking, or charred smell.
Patients who don't use supplemental oxygen who have devices that appear to be functioning normally can continue to use the equipment until they receive replacements, advised ResMed, which is headquartered in San Diego.
The seven devices that short circuited represent 0.02% of ResMed devices in use.
The S8 flow generators included in the recall were manufactured from July 2004 though May 15, 2006 with these serial numbers stamped of the bottom:
ResMed said patients who have an affected device will receive a replacement S8 flow generator. Patients were encouraged to visit http://www.resmed.com/en-us/s8program/s8program.html for more information.