VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8 CH

Description of Event or Problem

PATIENT RECEIVED A 2ND DEGREE BURN FROM MID HAND TO MID FOREARM. THE PATIENT REPORTEDLY WAS POSITIONED WITH HANDS ABOVE HEAD AND SEPARATED (NOT TOUCHING). PROTECTIVE PADDING WAS USED TO PREVENT SKIN CONTACT. IT WAS REPORTED THAT PATIENT MAY HAVE MOVED - CROSSING OR TOUCHING THE HAND TO FOREARM DURING THE BREAST MRI EXAM CAUSING "LOOPING." LOOPING IS KNOWN TO POTENTIALLY CAUSE A RADIO FREQUENCY (RF) BURN AT POINT OF CONTACT. THE GE SIGNA 1.5T, 8CH MRI SCANNER WAS USED IN CONJUNCTION WITH THE SENTINELLE BREAST MRI COIL AT TIME OF EVENT. PATIENT WAS TREATED IN EMERGENCY DEPARTMENT FOR 2ND DEGREE BURN. PATIENT REPORTEDLY SUSTAINED NO PERMANENT DAMAGE OR INJURY.

Additional Manufacturer Narrative

IT IS SUSPECTED THAT LOOPING OF THE PATIENT'S ARMS CAUSED THE SUSTAINED BURN. LOOPING IS KNOWN TO POTENTIALLY CAUSE AN RF BURN AT POINT OF CONTACT. THERE IS NO KNOWN ASSOCIATION OF THE EVENT AND OUR DEVICE. SENTINELLE BREAST MRI COIL FOR GE: USER MANUAL-SMI-0426 CONTAINS THE FOLLOWING WARNING: WARNING: ENSURE THAT THE PATIENT DOES NOT FORM A LOOP WITH ANY BODY PARTS. DO NOT ALLOW PATIENTS TO TOUCH ANY PART OF THE RIGHT HAND OR ARM TO ANY PART OF THE LEFT HAND OR ARM. THE LOOP FORMED BY DOING SO COULD CAUSE AN RF BURN AT THE POINT OF CONTACT. USE PADS TO ENSURE THE PATIENT'S HANDS DO NOT TOUCH ANY METAL FEATURES OF THE VANGUARD. BE SURE TO EDUCATE THE PATIENT ACCORDINGLY AND CHECK THE PATIENT'S POSITION IMMEDIATELY BEFORE THE SCAN. THE AFFECTED SENTINELLE MRI BREAST COIL WAS INSPECTED BY SENTINELLE SERVICE PERSONNEL POST EVENT. NO COMPONENT OR SYSTEM FAULTS WERE IDENTIFIED DURING THE INSPECTION. SEE SCANNED PAGE.