ANODYNE THERAPY
Received Jan 3, 2007 · Event occurred Dec 7, 2006
Report 1055581-2007-00001 · MDR key 805589
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
4980006
Lot number
NA
Product problems
- Overheating of Device
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE THERAPY PADS ON THEIR PROFESSIONAL UNIT WERE GETTING TOO WARM AND RETURNED IT FOR EVALUATION. DURING EVALUATION OF THE UNIT, THE DUTY CYCLE WAS FOUND TO BE DEFECTIVE. THERE WAS NO ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
THIS 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 MAY CAUSE AN ADVERSE EVENT. THE DESIGN AND FUNCTIONALLY OF ANODYNE'S DEVICE DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN OUR MDR.