GENERAL ELECTRIC
Received Feb 1, 2002 · Event occurred Jan 15, 2002
Report MW1023987 · MDR key 375484
Device
Generic name
Dual Tmj Coil 3"
Manufacturer
General ElectricModel number
2127315Catalog number
*
Lot number
*
Product problems
- Disconnection
- Heat
Patient
39 YR
- Erythema
- Pain
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
THIS PT WAS FOR A TMJ MRI EXAM. THE SPECIFIC COIL USED IS MADE FOR TMJ'S AND HAS A DUAL COIL SYSTEM. THE CORDS THAT CONNECT THE COIL FROM COIL TO PLUGGING INTO THE BODY COIL ARE ENCASED IN A HEAVY MATERIAL. ON ONE SIDE THE COIL HAD DISCONNECTED, BUT THAT WAS NOT OBSERVABLE DUE TO THE COVERING OF THE MATERIAL. INITIALLY THIS COIL DID NOT WORK AS THEY TRIED DIFFERENT THINGS BUT WERE ABLE DO A 10 SEC SCAN. THE PT SCREANED AND THEY BROUGHT PT OUT OF THE SCANNER. THE PT'S LEFT EAR WAS RED AND VERY WARM TO TOUCH. PT DECIDED TO LEAVE WITH EAR LOOKING BETTER. THEY OFFERED TO HAVE A DR LOOK AT THIS PT'S EAR. THE PT DID DECLINE. PT WOULD LIKE IN THIS SPACE TO CONTINUE THAT RADIO FREQUENCY BURNS ARE NOT AS COMMON AND HAVE BEEN DOCUMENTED AT OTHER SITE. THEY NEEDED TO DISCONTINUE EXAM, AND TO REPORT THIS EVENT.