ANODYNE THERAPY
Received Jun 7, 2007 · Event occurred Dec 20, 2006
Report 1055581-2007-00009 · MDR key 862945
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498006
Lot number
NA
Product problems
- Overheating of Device
- Defective Component
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE UNIT INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND DUTY CYCLE FAILURE WAS DETECTED. NO ADVERSE EVENT WAS REPORTED, HOWEVER, THIS TYPE OF MALFUNCTION COULD POTENTIALLY CAUSE AN ADVERSE EVENT. THE DESIGN AND FUNCTIONALITY OF ANODYNE'S DEVICES DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN OUR MDR.
Description of Event or Problem
CUSTOMER REPORTED THAT THE THERAPY PADS ON THEIR PROFESSIONAL UNIT WERE GETTING TOO WARM. WE REQUESTED THAT THEY RETURN THE UNIT FOR EVALUATION, AND THEIR DUTY CYCLE WAS FOUND TO BE DEFECTIVE. THERE WAS NO ADVERSE EVENT REPORTED.