4 CH SENSE SHOULDER COIL 1.5T

Additional Manufacturer Narrative

THE COIL WAS RETURNED FROM THE CUSTOMER AND AN ENGINEERING EVALUATION WAS CONDUCTED. ENGINEERING CONDUCTED EXTERNAL AND INTERNAL VISUAL INSPECTIONS WITH NO DEFECTS OR INDICATION OF BURN FOUND. BENCH AND SYSTEM TESTS WERE PERFORMED TO FIND POTENTIAL CAUSES THAT MIGHT HAVE RESULTED IN PATIENT HARM. IT WAS OBSERVED THAT THE BALUN IN THE BASEPLATE WAS OUT OF SPECIFICATION AND THIS MIGHT HAVE BEEN DUE TO AGED COMPONENTS. THIS IS A SINGLE FAULT, AND THE CABLE BALUN SHOULD HAVE BEEN ABLE TO HANDLE THE KEEP THE CABLE CURRENTS TO A LOW ENOUGH VALUE THAT NO HARM WAS CAUSED. CABLE B1 TESTS REVEALED THAT THE CABLE CURRENTS WERE INDEED WITHIN THE SAFE OPERATING RANGE FOR A SINGLE FAULT CONDITION. AN RF POWER MUCH HIGHER THAN THE ONE USED FOR THE PATIENT SCAN WAS USED TO MEASURE POTENTIAL RF HEATING. NO EXCESSIVE HEATING WAS OBSERVED. FROM THIS DATA, IT WAS NOT EASY TO REPRODUCE THE HARM CONDITION. HOWEVER, IF A SECOND FAULT, IN THE FORM OF THE OPERATOR INCORRECTLY ROUTING THE CABLES CLOSE TO THE HUMAN BODY OCCURRED, THEN WITH A SINGLE FAULT CONDITION SUCH HARM MAY BE POSSIBLE. IN CONCLUSION, ONE OF THE BALUNS WAS SLIGHTLY MISTUNED AND RESULTED IN A SINGLE FAULT CONDITION. THE COIL WAS TESTED IN THIS SINGLE FAULT CONDITION, AND AN UNSAFE CONDITION WAS NOT OBSERVED. ONE MAY, HOWEVER, ENVISION THAT A SECOND FAULT CONDITION HAPPENED WHEN THE CABLE WAS ROUTED VERY CLOSE TO PATIENT¿S ARM. THE HARM MIGHT HAVE OCCURRED DUE TO OPERATOR ERROR WHILE ROUTING THE CABLE. A WARNING IS INCLUDED IN THE INSTRUCTIONS FOR USE (4535-302-91111 REV. 7) INVIVO MAGNETIC RESONANCE IMAGING COILS WHICH STATES: DO NOT CROSS OR LOOP CABLES. ARCING AND PATIENT BURNS COULD RESULT. ROUTE CABLES OUT OF THE MAGNET SO THAT THEY DO NOT TOUCH THE PATIENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem

BURN INCIDENT DURING MR EXAM OF RIGHT SHOULDER (RIGHT UPPER ARM) AFTER THE EXAM THE PATIENT COMPLAINED OF A HEATING SENSATION ON THE RIGHT ARM DURING THE EXAM. THE NURSE DID NOT FIND ANY MAJOR INJURIES. THE PATIENT WENT HOME WITHOUT ANY FURTHER ACTIONS/TREATMENT. TWO WEEKS LATER THE PATIENT CONTACTED HOSPITAL ABOUT BURN INJURY. AT THAT MOMENT A 3RD DEGREE INJURY APPROX. 5 CM WAS OBSERVED.