DS ANTERIOR 1.5T

Additional Manufacturer Narrative

EVENT IS UNDER INVESTIGATION AND UPDATES WILL BE PROVIDED ON A LATER DATE. (B)(4).

Description of Event or Problem

A MALE PATIENT WAS POSITIONED HEAD FIRST SUPINE AND SCANNED FOR PELVIS EXAMINATION USING THE DS ANTERIOR 1.5T COIL. THE PATIENT EXPERIENCED A HEATING SENSATION AND 2ND DEGREE BURNS RESULTING IN BLISTERS ( APPROX. 2CM X 2CM) ON THE INSIDE OF BOTH INNER THIGHS.

Additional Manufacturer Narrative

BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE, THERE IS NO INDICATION OF A MALFUNCTION OF THE COIL USED THAT CONTRIBUTED. THE INJURIES ON THE INSIDE OF THE PATIENT¿S INNER THIGHS ARE CONSISTENT WITH INJURIES CAUSED BY SO CALLED SKIN-TO-SKIN CONTACT. ALTHOUGH PADDING WAS USED BETWEEN THE LEGS THIS COULD NOT PREVENT THE UPPER INNER THIGHS FROM TOUCHING. IT WAS STATED THAT THERE WAS POTENTIAL FOR SKIN-TO-SKIN CONTACT CLOSE TO THE AFFECTED AREA. FURTHERMORE, 3 SCANS ON HIGH SAR LEVEL WERE ADMINISTERED THAT MAY HAVE CONTRIBUTED.