OPTIMA MR360

Description of Event or Problem

IT WAS REPORTED A PATIENT SUSTAINED TWO FULL-THICKNESS BURNS, LOCATED NEAR BOTH ELBOWS, DURING AN MR EXAMINATION OF THE SKULL AND LUMBOSACRAL SPINE WHILE UNDER SEDATION. THE INJURIES WERE DIAGNOSED AS THIRD-DEGREE BURNS. THE PATIENT UNDERWENT SURGICAL DEBRIDEMENT AND IS CURRENTLY RECEIVING FOLLOW-UP CARE WITH PLASTIC SURGERY.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS TIANJIN - NO.266 JINGSAN ROAD, TIANJIN AIRPORT ECONOMIC AREA CHINA TIANJIN, 300308. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. D4: PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.