SENSE XL TORSO COIL, 3.0T

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 THE SKIN REDDENING TO THE RIGHT HIP, DURING PROSTATE SCAN, USING 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

AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THE MR SYSTEM WAS WORKING CORRECTLY. THERE WAS NO INDICATION OF A MALFUNCTION WHICH WOULD HAVE CONTRIBUTED TO THE INCIDENT. DUE TO FAILING SIGNAL-TO-NOISE, WHICH IS AN IMAGE QUALITY ISSUE, AND OUT OF PRECAUTION, THE COIL WAS REPLACED ON SITE. THE PATIENT WAS OBESE AND HIS HIPS MOST LIKELY HAVE BEEN TOO CLOSE OR TOUCHING THE BORE. THE PADDING WAS NOT USED TO AVOID THE BODY-TO-BORE WALL CONTACT. THE OBSERVED SKIN REDDENING CAN BE EXPLAINED BY CLOSE CONTACT WITH THE BORE WALL. CONTRIBUTING FACTORS TO THIS INCIDENT: THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 2.7 KJ/KG EXCEEDED THE RECOMMENDED LIMIT OF 2.0 KJ/KG FOR PATIENTS WITH IMPAIRED THERMOREGULATION. 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 WAS ELDERLY, WHICH CAN INFLUENCE THE PATIENT¿S THERMOREGULATORY CAPABILITY. BASED ON THE OUTCOME OF THE INVESTIGATION IT WAS DETERMINED THAT THIS CASE IS NOT LINKED TO THE KNOWN TORSO XL ISSUES AS MENTIONED IN (B)(4).