MR 5000 SERIES

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED THE BURN, WHILE UNDERGOING A BRAIN AND SPINE/NECK MRI SCAN WITH CONTRAST. THE EXAM WAS A LONG DURATION APPROXIMATELY 90 MINUTES WITH THE PATIENT SEDATED. PER THE DIAGRAM ON THE HEATING QUESTIONNAIRE, THE PATIENT 'S RIGHT FOREARM AND AREA HAD AN AREA OF BLISTERING. THE BURN DEPTH OR DEGREE IS REPORTED AS "1". THE BURN EMERGED SHORTLY AFTER THE EXAM. IT IS UNKNOWN IF THE BURN WILL HEAL COMPLETELY. LOCAL TOPICAL TREATMENT WAS PERFORMED, THIS WAS NOT SPECIFIED. A DIGITAL PHOTO WAS RECEIVED FOR REVIEW. THE PATIENT'S RIGHT ARM IS SHOWN WITH A LARGE AREA OF RAISED LINEAR SHAPED SWELLING WHICH APPEAR TO BE A DEVELOPING BLISTER. THE AREA EXTENDS FROM THE PATIENT'S ELBOW DOWN PAST THE FOREARM. THE SKIN APPEARS INTACT AT THE TIME THE PHOTO WAS TAKEN. THE SIZE OF THE BLISTER MEETS THE CRITERIA FOR A SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

Additional Manufacturer Narrative

AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THE MR SYSTEM AND COIL USED IN THIS CASE WERE WORKING CORRECTLY. THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL USED THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE COILS USED FOR THE SCAN WERE THE MSK M AND DS HEAD COILS. THE TECHNICIAN REPORTED THAT COIL MSK M WAS NOT HOT. A DIGITAL PHOTO WAS RECEIVED FOR REVIEW. THE PATIENT'S RIGHT ARM IS SHOWN WITH A LARGE AREA OF RAISED LINEAR SHAPED SWELLING WHICH APPEAR TO BE A DEVELOPING BLISTER. THE AREA EXTENDS FROM THE PATIENT'S ELBOW DOWN PAST THE FOREARM AND APPEARS TO MATCH THE SHAPE OF THE COIL CABLE. THEREFORE, IT WAS CONCLUDED, THAT THE BURN MOST LIKELY OCCURRED DUE TO WRONG POSITION OF PATIENT OR COILS. THE COIL CABLE WAS IN DIRECT CONTACT WITH THE PATIENTS ARM, NO PADDING WAS USED TO PREVENT THIS CONTACT. CONTRIBUTING FACTORS IN THIS CASE ARE AS FOLLOWS: THE PATIENT'S CONDITION, OBESE AND SUFFERING FROM DIABETES, IS CONSIDERED TO BE A CONTRIBUTING FACTOR. THE THERMOREGULATION OF SUCH PATIENTS IS KNOWN TO BE IMPAIRED. THE PATIENT WAS SEDATED. THE THERMOREGULATION OF SEDATED PATIENTS IS KNOWN TO BE IMPAIRED. THE PATIENT WAS UNABLE TO SENSE OR COMMUNICATE DISCOMFORT OR PAIN. THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 2.71 KJ/KG EXCEEDED THE RECOMMENDED LIMIT OF 2.0 KJ/KG FOR PATIENTS WITH IMPAIRED THERMOREGULATION.