ANODYNE THERAPY
Received Aug 30, 2011 · Event occurred Aug 4, 2011
Report 1055581-2011-00003 · MDR key 2251633
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498026
Lot number
NA
Product problems
- Break
- Device Operates Differently Than Expected
- Temperature Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PURCHASING DEPARTMENT REPORTED THEIR UNIT WAS NOT WORKING PROPERLY AND REQUESTED TO RETURN IT FOR EVAL. NO ADVERSE EVENT WAS REPORTED. EVAL IDENTIFIED BROKEN WIRES THAT CAUSED ONE THERAPY PAD OF THE UNIT TO OPERATE AT HIGHER THAN NORMAL TEMPERATURES AND THIS COULD CAUSE AN ADVERSE EVENT IF IT WERE TO RECUR.
Additional Manufacturer Narrative
THE UNIT HAS BEEN RETURNED TO ANODYNE FOR EVAL. THE UNIT WAS FOUND TO HAVE BROKEN WIRES THAT CAUSED ONE THERAPY PAD TO OPERATE AT HIGHER THAN NORMAL TEMPERATURES. THE NUMBER OF MALFUNCTIONS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND THESE EVENTS.