TOSHIBA
Received Apr 8, 2011 · Event occurred Mar 2, 2011
Report 2020563-2011-00006 · MDR key 2046284
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING THE MRI PROCEDURE A PAD WAS NOT PLACED BETWEEN THE PATIENT'S LEGS THE PATIENT HAS NOT RETURNED TO BE EXAMINED AT THE CUSTOMER FACILITY SO THEY ARE UNABLE TO DETERMINE THE SEVERITY OF THE BURN. THE COIL WAS INSPECTED FOR DEFECTS AND NO PROBLEMS WERE FOUND. THE COIL IS OPERATING NORMALLY. WE ARE IN CONTACT WITH THE FACILITY FOR ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
IT HAS BEEN CONCLUDED FROM THE MANUFACTURER'S INVESTIGATION INTO THIS INCIDENT THAT: THERE WAS NO PROBLEM FOUND WITH THE COIL. IT IS BELIEVED THAT THE PATIENT'S SETTING WAS INCORRECT. THERE IS A WARNING IN THE SAFETY MANUAL AS FOLLOWS: "WARNING: THE FORMATION OF A HIGH FREQUENCY CURRENT LOOP IN THE PATIENT'S BODY IN THE HIGH-FREQUENCY MAGNETIC FIELD GENERATION AREA" WE WERE UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION FROM THE CUSTOMER SITE. THE INVESTIGATION IS NOW COMPLETE.
Description of Event or Problem
A PATIENT REPORTED TO THE CUSTOMER THAT ON (B)(6) 2011 THEY HAD A BURN ON THEIR INNER THIGH WHICH THEY ATTRIBUTED TO HAVING HAD A MRI SCAN ON (B)(6) 2011.