MalfunctionILY
ANODYNE THERAPY
Received Nov 15, 2006 · Event occurred Oct 19, 2006
Report 1055581-2006-00037 · MDR key 788172
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
120Catalog number
4980004
Lot number
NA
Product problems
- Heat
- Defective Component
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PT REPORTED THAT, THE THERAPY PADS ON THEIR HOME 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 BY THE PT.
Additional Manufacturer Narrative
COMPONENT FAILURE OF THE DUTY CYCLE DIRECTLY CONTRIBUTED TO THIS ADVERSE EVENT. THE DESIGN AND FUNCTIONALITY 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'S.