Medical device manufacturer ResMed has recalled nearly 300,000 continuous positive air pressure, or CPAP, units it produced between July 2004 and mid-May 2006. The voluntary recall potentially affects hundreds of thousands of patients around the globe who use the devices to ease symptoms of obstructive sleep apnea or similar disorders.
Manufacturer Recalls Sleep Apnea Breathing Devices
By News Staff
5/18/2007
The recall was spurred by discovery that the power supply connector in ResMed's early production S8 flow generators could potentially short-circuit. According to a ResMed press release, (PDF file: 2 pages / 29 KB. More about PDFs.) patients may continue to use their devices until a replacement arrives but should make sure the device is placed on a hard clean surface clear of other items and that it does not exhibit signs of electrical failure.
ResMed says it will contact patients about replacing affected units, but family physicians also can encourage their patients to call (888) 899-8991 or to visit ResMed's Web site for more information on the recall. A Frequently Asked Questions document on the Web site includes information on how to request a replacement unit, lists the serial numbers of affected devices, gives instructions on how to find the serial number on the device and addresses other related issues.
As always, the FDA encourages clinicians to report adverse reactions or quality problems experienced with the use of this or other medical products to its MedWatch Safety Information and Adverse Event Reporting Program.
ResMed says it will contact patients about replacing affected units, but family physicians also can encourage their patients to call (888) 899-8991 or to visit ResMed's Web site for more information on the recall. A Frequently Asked Questions document on the Web site includes information on how to request a replacement unit, lists the serial numbers of affected devices, gives instructions on how to find the serial number on the device and addresses other related issues.
As always, the FDA encourages clinicians to report adverse reactions or quality problems experienced with the use of this or other medical products to its MedWatch Safety Information and Adverse Event Reporting Program.
