SENSE XL TORSO COIL, 1.5T MK2

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED 2ND DEGREE BURN, WITH A BLISTER SIZE OF A NICKEL DURING PELVIS SCAN WITH SENSE XL TORSO COIL. THE TORSO XL COIL HAS BEEN INVESTIGATED VIA ISSUE IMPACT ASSESSMENT AND HEALTH HAZARD EVALUATION FOR PREVIOUS BURN INCIDENTS. IT WAS CONCLUDED THAT THERE IS A REASONABLE PROBABILITY THAT USE OF OR EXPOSURE TO THIS TYPE OF COIL WILL CAUSE MEDICALLY REVERSIBLE OR TRANSIENT ADVERSE HEALTH CONSEQUENCES. AS A RESULT, THIS ISSUE HAS BEEN DETERMINED TO BE A POTENTIAL RISK TO HEALTH.

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Additional Manufacturer Narrative

THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE INJURY, A SMALL BLISTER ON THE ABDOMEN OF THE PATIENT WAS MOST LIKELY CAUSED BY LOCALIZED HEATING INSIDE THE XL TORSO COIL. THIS LOCALIZED HEATING COULD HAVE EMANATED FROM THE SCANNING PARAMETERS USED IN COMBINATION WITH THE SCAN DURATION. UNFORTUNATELY NO LOGFILE IS AVAILABLE TO CONFIRM THIS. WE CONSIDER THIS INCIDENT TO BE ATTRIBUTED TO THE ONE MENTIONED IN THE COMMUNICATION SURROUNDING CORRECTION 2024-PD-MR-008. CONTRIBUTING FACTORS: THE PATIENT WAS OBESE. THE THERMOREGULATION OF OBESE PATIENTS IS KNOWN TO BE IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. THE PATIENT VENTILATION WAS NOT USED, IT IS RECOMMENDED TO USE VENTILATION AS IT SUPPORTS THE COOL DOWN MECHANISM.