SENSE XL TORSO COIL, 1.5T MK2

Additional Manufacturer Narrative

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

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED 1ST DEGREE BURN (SKIN REDDENING) DURING LEFT THIGH EXAMINATION TO THE LATERAL LEFT THIGH 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

THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE INJURY, A SKIN REDDENING TO THE LATERAL LEFT THIGH 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 HIGH SAR VALUES. WE CONSIDER THIS INCIDENT TO BE ATTRIBUTED TO THE ONE MENTIONED IN THE COMMUNICATION SURROUNDING CORRECTION 2024-PD-MR-008. CONTRIBUTING FACTORS TO THIS INCIDENT ARE AS FOLLOWS: 4 SCANS WITH HIGH SAR VALUES (> 2 W/KG, AT 2.98-4.0 W/KG) WERE EXECUTED IN A SHORT PERIOD OF TIME, ALLOWING NO COOL DOWN TIME FOR THE PATIENT. IN ADDITION TO THAT, THE PATIENT VENTILATION WAS NOT AT THE HIGHEST LEVEL. LEVEL 5 IS RECOMMENDED FOR HIGH SAR SCANS, IT SUPPORTS THE COOL DOWN MECHANISM.