TOSHIBA
Received Apr 5, 2010 · Event occurred Feb 26, 2010
Report 2020563-2010-00003 · MDR key 1654591
Device
Generic name
Device #1: Coil, Speeder Spine
Manufacturer
Toshiba Medical Systems CorpModel number
MJAS-147A/E1Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burning Sensation
Narrative
Description of Event or Problem
DURING A HAMSTRING EXAM, A PT COMPLAINED OF BEING HOT AND THAT SHE FELT A BURNING SENSATION ON HER LEGS. AT THE POINT THE PT COMPLAINED OF THE BURNING SENSATION ON HER LEGS, THE TECHNOLOGIST STOPPED THE EXAM.
Additional Manufacturer Narrative
THE PROBLEM OCCURRED ON (B) (6) 2010 AND TOSHIBA SERVICE WAS NOTIFIED ON 03/01/2010. THE PT WAS SENT HOME WITH NO TREATMENT. THE HOSPITAL CONTINUED TO USE THE SYSTEM AND AFFECTED COILS WITHOUT ANY PROBLEMS AFTER THIS PT. ADDITIONALLY, THE TECHNOLOGIST STATED THAT NO COILS OR CABLES WERE TOUCHING THE PT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HOSPITAL FOR THE INVESTIGATION. EVALUATION IS IN PROCESS. RESULTS: EVALUATION IS IN PROCESS, THEREFORE, NO RESULTS OF THE INVESTIGATION. CONCLUSION: EVALUATION IS IN PROCESS. NOTE: SAME AS 2020563-2010-0004 - MEDWATCH FOR TWO DEVICES.