ANODYNE THERAPY
Received Jan 9, 2010 · Event occurred Nov 13, 2009
Report 1055581-2009-00004 · MDR key 1580004
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498019
Lot number
NA
Product problems
- Device Operates Differently Than Expected
Patient
82 YR
- No Code Available
Narrative
Description of Event or Problem
HOSPITAL NOTIFIED COMPANY THAT THE ENERGY BARS FLUCTUATE ON THEIR SYSTEM. COMPANY WAS SUBSEQUENTLY NOTIFIED THAT THE HOSPITAL ALSO EXPERIENCED AN ADVERSE EVENT.
Additional Manufacturer Narrative
HOSPITAL NOTIFIED COMPANY THAT THE ENERGY BARS FLUCTUATE ON THEIR SYSTEM. THIS SYSTEM WAS RETURNED FOR EVALUATION, AND THE POTENTIOMETER SWITCH WAS FOUND TO BE DEFECTIVE, AND REPLACED. COMPANY DID NOT SUBMIT AN MDR AT THAT TIME AS THIS DEFECT WOULD NOT CAUSE THE SYSTEM TO OPERATE AT UNSAFE TEMPERATURES. ON DECEMBER 14, COMPANY WAS NOTIFIED THAT THE HOSPITAL HAD ALSO EXPERIENCED AN ADVERSE EVENT. DETAILS OF THIS ADVERSE EVENT ARE NOT KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN SUFFICIENT INFORMATION IS AVAILABLE.