INVIVO

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 A PATIENT SUFFERED A 2ND DEGREE BURN ON THE CHEST WHEN USING THE CARDIAC COIL.

Additional Manufacturer Narrative

AN 80-YEAR-OLD MALE PATIENT WAS POSITIONED HEAD-FIRST AND SUPINE FOR A NECK EXAMINATION USING THE SENSE CARDIAC COIL 1.5T. DURING THE EXAMINATION, A BLISTER INDICATING A MINOR BURN WAS OBSERVED AT THE CENTER OF THE PATIENT'S CHEST. IT WAS NOTED THAT THERE WAS A BLISTER AND A BANDAGE WAS APPLIED. A SECOND-DEGREE BURN OF UNKNOWN SIZE WAS REPORTED. ALTHOUGH NO FORMAL MEDICAL INTERVENTION WAS UNDERTAKEN, THE CLINICAL NATURE OF THE BURN SUGGESTS THAT REFERRAL TO A SPECIALIZED BURN CENTER OR INPATIENT HOSPITALIZATION WOULD TYPICALLY BE THE STANDARD OF CARE TO PREVENT PERMANENT DAMAGE. HOWEVER, ONLY A BANDAGE WAS APPLIED, AND IT IS EXPECTED THAT THE INJURY WILL HEAL COMPLETELY. AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THE MR SYSTEM AND COIL USED IN THIS CASE WERE WORKING CORRECTLY. THERE WAS NO INDICATION OF A MALFUNCTION WHICH WOULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS NOTED THAT THE CUSTOMER DID NOT POSSESS A DEDICATED NECK COIL; THEREFORE, THE NECK EXAMINATION WAS PERFORMED USING THE SENSE CARDIAC COIL, WHICH, ACCORDING TO THE PHILIPS APPLICATION GUIDE, IS NOT INTENDED FOR HEAD OR NECK IMAGING. THE REPORTED BURN CAN BE ATTRIBUTED TO THE POSITIONING OF THE COIL CABLE, WHICH WAS CLOSE TO THE AFFECTED AREA AND IN DIRECT CONTACT WITH THE PATIENT. NO PADDING WAS USED TO PREVENT THE CABLE-TO-SKIN CONTACT. CONTRIBUTING FACTORS TO THIS INCIDENT ARE FOLLOWING: THE PATIENT WAS ELDERLY, WHICH CAN INFLUENCE THE PATIENT¿S THERMOREGULATORY CAPABILITY. FOUR SCANS WITH HIGH SAR VALUES (> 2 W/KG) WERE EXECUTED. HIGH SAR SCANS ARE A BIGGER CHALLENGE FOR THE COOL DOWN MECHANISM THAN LOW SAR SCANS. THE PATIENT VENTILATION WAS NOT AT THE HIGHEST LEVEL. LEVEL 5 IS RECOMMENDED FOR HIGH SAR SCANS; IT SUPPORTS THE COOL DOWN MECHANISM.