VANGUARD BREAST MRI AUXILIARY TABLE W/8CH COIL

Description of Event or Problem

DURING ROUTINE BREAST SCREENING MRI EXAM, PATIENT COMPLAINED OF BURNING SENSATION AT STERNUM. AFTER LAST SCAN, PATIENT WAS REMOVED FROM SCANNER, AND EXAMINED BY THE CHARGE TECHNOLOGIST, WHO REPORTED REDNESS "LIKE SUNBURN" CONFINED TO THE PATIENT'S STERNUM. RADIOLOGIST EXAMINED THE PATIENT LATER THE SAME DAY AND SAID REDNESS HAD LARGELY RESOLVED AND HE COULDN'T TELL WHETHER THERE WAS A BURN. MANUFACTURER (SENTIELLE MEDICAL INC) ASKED THE CLINIC TO DISCONTINUE USE OF THE DEVICE PENDING INVESTIGATION, WHICH IS ONGOING. AT THIS TIME THERE IS NO EVIDENCE OF ABNORMAL OPERATION, OR PAST HEATING OF THE DEVICE. IT IS QUITE POSSIBLE THAT THE REDNESS AND BURNING SENSATION WAS CAUSED BY PATIENT WEIGHT BORNE BY STERNUM SUPPORT. SENTINELLE MEDICAL INC. IS CONTINUING TO INVESTIGATE.