TOSHIBA

Description of Event or Problem

AT THE COMPLETION OF AN MRI EXAM, THE PATIENT STATED TO TECHNOLOGIST THAT SHE FELT WARM IN HER LOWER ABDOMEN.

Additional Manufacturer Narrative

THE PATIENT WAS SCHEDULED FOR AN MRI OF THE LUMBAR SPINE. AT THE COMPLETION OF THE EXAM, THE PATIENT STATED TO THE TECHNOLOGIST THAT SHE FELT WARM IN HER LOWER ABDOMEN (WITHIN A FOLD OF SKIN ON HER RIGHT ABDOMEN BELOW THE NAVEL, ABOVE THE PELVIS). THE PATIENT WAS WEARING SWEATPANTS AND A SHIRT; THE SWEATPANTS WAIST WAS EXTENDED ABOVE THE POINT OF THE AREA THAT FELT WARM. THE TECHNOLOGIST STATED SHE COULD SEE NO INDICATION OF IRRITATION AT THE AREA INDICATED BY THE PATIENT. SHE THEN ADDED THAT THERE APPEARED TO BE IRRITATION OUTSIDE OF THE INDICATED AREA, UNDER THE APRON (FOLD OF SKIN) THAT SHE TOOK TO BE THE PATIENT'S BODY HABITUS. THE PATIENT STATED IN A FOLLOW-UP CALL THE NEXT DAY THAT SHE HAD DEVELOPED A BLISTER. THE PATIENT DID NOT COMPLAIN DURING THE EXAM, AND THE CALL BELL WAS GIVEN TO THE PATIENT DURING THE EXAM. THE COIL USED FOR THE PROCEDURE REMAINS IN USE AT THE FACILITY. FINAL EVALUATION IN PROCESS.

Additional Manufacturer Narrative

AN INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER AND IT WAS DETERMINED THAT THE CAUSE OF THE INCIDENT WAS USER ERROR. INSTRUCTIONS TO AVOID THIS PROBLEM FROM HAPPENING IS DESCRIBED IN THE DEVICE'S SAFETY AND OPERATION MANUALS. IT WAS DETERMINED THAT IF THE SKIN SURFACES OF TWO DIFFERENT PARTS OF A PATIENT'S BODY COME INTO CONTACT, A CONDUCTIVE LOOP MAY FORM IN THE PATIENT'S BODY. PER THE MANUFACTURER, FOAM PADS OR OTHER APPROPRIATE MATERIAL SHOULD HAVE BEEN PLACED BETWEEN THE PATIENT'S INNER THIGHS TO AVOID CONTACT. THE INVESTIGATION IS NOW COMPLETE.