1.5T 8 CHANNEL TORSO COIL

Additional Manufacturer Narrative

IT HAS BEEN DOCUMENTED THAT THE PT WAS WARMED IN THE AREA WHERE THE COIL CABLE WAS ROUTED BETWEEN THE PT'S LEGS. THE CUSTOMER WAS USING A DAMAGED COIL: CABLE INSULATION HAD PULLED AWAY FROM THE CONNECTOR FOR THE UPPER COIL. THE CABLE WAS ALSO SLIGHTLY MODIFIED: VELCRO WAS PLACED UNDERNEATH THE CONNECTOR ON THE TOP OF THE COIL SO IT WOULD NOT COME UNPLUGGED. THE OPERATOR MANUAL STATES THE FOLLOWING: "DO NOT USE SURFACE COILS WITH EXPOSED METAL CONDUCTORS OR DAMAGED INSULATION. SKIN CONTACT WITH METAL CONDUCTORS CAN CAUSE BURNS." "THE ELECTRICAL AND MECHANICAL ASSEMBLIES AND PARTS OF THE COIL MUST BE USED WITH CARE AND SHOULD BE ROUTINELY INSPECTED. BEFORE USING THE COIL, VISUALLY CHECK IT TO ENSURE THERE IS NO EXTERNAL DAMAGE. DO NOT USE THE COIL IF THE HOUSING OR CABLE IS BROKEN."

Description of Event or Problem

IT WAS REPORTED THAT A PT COMPLAINED OF A BURNING SENSATION ON THE LEGS AFTER A MAGNETIC RESONANCE (MR) EXAM. THE TORSO COIL CABLE WAS REPORTEDLY POSITIONED BETWEEN THE PT'S LEGS. THE HOSPITAL STATED THAT THE COIL CABLE WAS NOT TOUCHING THE PT'S SKIN. THE DAY AFTER THE EXAM, THE PT CALLED AND REPORTED THAT HE HAD TWO SMALL BLISTERS ON EACH CALF AND THE SIZE OF EACH BLISTER WAS LESS THAN A DIME. THE PT HAS NOT UNDERGONE ANY MEDICAL TREATMENT FOR THE BLISTERS. THE PT REFUSED TO RETURN TO THE MR DEPARTMENT FOR THE RADIOLOGIST TO EXAMINE THE PT. THE PT TOLD THE HOSPITAL HE ONLY CALLED SO THEY WOULD BE AWARE OF THE BLISTERS THAT HAD FORMED AFTER UNDERGOING THE MR EXAM. THE PT WAS POSITIONED FEET FIRST, SUPINE WITH ARMS AT SIDE. GE RECOMMENDED PADS WERE USED DURING THE SCAN. THERE WAS NO SKIN-TO-SKIN CONTACT REPORTED BY THE TECH. THE PULSE SEQUENCES USED WERE: (B)(4). THE PT WAS SCANNED FOR EIGHT SERIES. (B)(4).