ANODYNE THERAPY
Received Feb 5, 2013 · Event occurred Dec 21, 2012
Report 1055581-2013-00001 · MDR key 2985387
Device
Generic name
Infrared Lamp
Manufacturer
Anodyne Therapy, LlcModel number
480Catalog number
498005
Lot number
NA
Product problems
- Power Conditioning Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND A TRANSISTOR FAILURE WAS DETECTED. NO ADVERSE EVENT WAS REPORTED, HOWEVER, THIS TYPE OF MALFUNCTION COULD POTENTIALLY CAUSE AN ADVERSE EVENT. THE NUMBER OF INCIDENTS 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 EVENTS OF THIS TYPE.
Description of Event or Problem
CUSTOMER REPORTED THAT THE BAR GRAPH DISPLAY DID NOT GO TO THE MAXIMUM SETTING. WE REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION, AND A TRANSISTOR WAS FOUND TO NOT BE WORKING AS INTENDED. THERE WAS NO ADVERSE EVENT REPORTED.