The volunteer was prone in a modified superman position.The imris flex coils were used and positioned on the volunteer's sides; one on the left with the coil cable going up and then down toward the feet.The other flex coil was on the right side of the volunteer in the same position.The flex coils were padded between the volunteer with a towel and wrapped with a flex wrap around the bed, body, and coils to hold them secured.Scanning was approximately forty-five minutes and round the forty-minute mark, the volunteer felt the left side coil become warmer.At the start of the next scan, the feeling became intense with heat and unbearable.The volunteer informed the staff of the discomfort and the scan was stopped.The mri and unrolled tape was removed and there were no red marks of heat or burn visible on the volunteer's skin.The customer did not return the coil(s) in question and continued to use them.The coils were tested previously by the manufacturer during preventive maintenance and were found to be performing within specification.In addition, the coils undergo daily qa testing by an or staff prior to any patient procedure.The particular serial numbers of the coils involved were not identified by the customer.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.
|