SENSE SHOULDER COIL 1.5T 4CH

Description of Event or Problem

THE PT WAS POSITIONED HEAD FIRST IN A SUPINE POSITION FOR AN MR SCAN. AN INVIVO SENSE SHOULDER COIL WAS USED WITH A PHILIPS MR 1.5T MAGNET SYSTEM. AFTER THE MR SCAN WAS COMPLETE, A SECOND DEGREE BURN (2 CM BLISTER) WAS OBSERVED ON THE SAME SHOULDER WHERE THE COIL WAS APPLIED.

Additional Manufacturer Narrative

(B)(4). (EVAL METHOD, RESULTS, CONCLUSIONS): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.