SENSE XL TORSO COIL, 3.0T

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED THE HEATING SENSATION AND SKIN REDDENING ON THE PATIENT'S LEFT INNER FOREARM (FIRST DEGREE BURN) DURING PROSTATE EXAMINATION WITH THE SENSE TORSO XL 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

A 71-YEAR-OLD MALE PATIENT WAS POSITIONED FEET-FIRST SUPINE FOR THE PROSTATE SCAN USING THE SENSE XL TORSO COIL (3.0T). DURING THE SCAN, HE EXPERIENCED A HEATING SENSATION AND NOTICED REDNESS ON HIS LEFT INNER FOREARM. HE WAS WEARING HOSPITAL-PROVIDED CLOTHING, WHICH WAS DRY. COIL PADDING WAS USED, ALTHOUGH NO EXTRA PADDING WAS APPLIED AT THE BEGINNING OF THE SCAN. AFTER 3-4 MINUTES, THE PATIENT PRESSED THE NURSE CALL BUTTON DUE TO DISCOMFORT, REPORTING A HEATING SENSATION ON HIS LEFT INNER FOREARM WHERE IT WAS IN CONTACT WITH THE COIL. ICE PACKS AND EXTRA PADDING WERE THEN APPLIED AT THAT SPOT. THE SCAN CONTINUED FOR ANOTHER 20 MINUTES. AFTER THE SCAN, THE PATIENT MENTIONED THAT AROUND 2 MINUTES BEFORE THE SCAN ENDED, HE FELT THE WARMTH RETURN BUT CHOSE NOT TO STOP THE EXAM. THE REPORTED HEATING SENSATION WAS CONSISTENT WITH A NON-SERIOUS, FIRST-DEGREE BURN. ABOUT 15¿20 MINUTES AFTER THE SCAN, THE PATIENT LEFT, AND THE REDNESS HAD SUBSIDED. 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 SKIN REDNESS WAS LIKELY CAUSED BY DIRECT CONTACT OR CLOSE PROXIMITY TO THE COIL CABLE. DUE TO THE PATIENT¿S WEIGHT (113.4 KG), KEEPING A 2¿4-INCH GAP BETWEEN THE COIL AND THE TOP OF THE BORE MIGHT HAVE BEEN DIFFICULT. SKIN-TO-SKIN CONTACT MAY ALSO HAVE CONTRIBUTED TO THE HEATING. BASED ON THE INFORMATION, IT APPEARS THE USER DID NOT FOLLOW THE SAFETY GUIDELINES DESCRIBED IN THE URGENT MEDICAL DEVICE RECALL (UMDR) (2024-PD-MR-008). CONTRIBUTING FACTORS TO THIS INCIDENT ARE AS FOLLOWS: THE PATIENT WAS OBESE AND ELDERLY. THE THERMOREGULATION OF THOSE PATIENTS IS KNOWN TO BE IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 3.389 KJ/KG EXCEEDED THE RECOMMENDED LIMIT OF 2.0 KJ/KG FOR PATIENTS WITH IMPAIRED THERMOREGULATION.