TOSHIBA

Description of Event or Problem

(B)(6) REPORTED THAT A PATIENT WAS BURNED ON HIS LEFT ARM DURING AN MR PROCEDURE USING A TORSO SPEEDER COIL

Additional Manufacturer Narrative

(B)(6) REPORTED THAT DURING AN MR PROCEDURE OF THE RIGHT HIP A PATIENT RECEIVED A BURN ON THE INSIDE OF HIS LEFT ELBOW. HE WAS REFERRED TO AN (B)(4) FACILITY FOR TREATMENT. PER (B)(6) THE PATIENT'S ARM WAS RESTING ON THE CABLE. EVALUATION IN PROCESS. NO RESULTS AS YET, UNTIL EVALUATION HAS BEEN COMPLETED.

Additional Manufacturer Narrative

THE MANUFACTURER HAS COMPLETED THEIR INVESTIGATION AND HAS DETERMINED THAT THE INCIDENT WAS CAUSED BY USER ERROR. BY ALLOWING THE PATIENT'S ARM TO TOUCH A CABLE FROM THE COIL, AN RF LOOP WAS FORMED WHICH CAUSED THE BURN. INSTRUCTIONS TO AVOID THIS SITUATION FROM HAPPENING, ARE INCLUDED IN THE SAFETY AND OPERATION MANUALS FOR THE COIL.REVIEW OF THE DATA OF THE COIL INSPECTION SHEET AFTER THE INCIDENT WAS NORMAL AND REVIEW OF THE RF TRANSMISSION DATA BEFORE AND AFTER THE INCIDENT WAS NORMAL AS WELL.