SENSE KNEE COIL 1.5T 8CH

Additional Manufacturer Narrative

MULTIPLE EFFORTS HAVE BEEN MADE TO GET THE PRODUCT BACK FROM THE CUSTOMER; HOWEVER, IT HAS BEEN UNSUCCESSFUL. THEREFORE, AN INVESTIGATION HAS BEEN COMPLETED BASED ON THE AVAILABLE INFORMATION INCLUDING PHOTOGRAPHIC EVIDENCE AND LOG FILES. IT WAS REPORTED THAT A MALE PATIENT WAS POSITIONED HEAD FIRST PRONE AND EXAMINED FOR A RIGHT ELBOW WITH THE SENSE KNEE COIL. THE KNEE COIL IS NOT RECOMMENDED FOR AN ELBOW EXAMINATION. BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL USED. THE INJURY ON THE LEFT FOREARM IS CONSISTENT WITH PATIENT HEATING CAUSED BY CLOSE PROXIMITY TO THE COIL CABLE WHICH LEADS TO AN RF LOOP. THE RF LOOP WAS CREATED BY THE BODY AND THE COIL CABLE. THE POINT WHERE THE LOOP CLOSES, IS THE PLACE OF CABLE-TO-SKIN CONTACT AND THE PLACE OF INJURY. THE COIL CABLE CAN STILL HAVE A NORMAL TEMPERATURE. THE FACT THAT THE INJURY WORSENED OVER TIME, CONFIRMS THAT IT IS AN RF BURN. FOR THE INJURY ON THE INSIDE OF THE RIGHT ELBOW NO DEFINITE CAUSE COULD BE DETERMINED. THE FOLLOWING FACTORS WERE OBSERVED THAT CAN EXPLAIN THE HEATING AS EXPERIENCED BY THE PATIENT AND MAY HAVE CONTRIBUTED TO THE INJURIES: 11 SCANS ON HIGH SAR VALUE WERE ADMINISTERED AND A TOTAL WHOLE BODY RF DOSE OF 6,9 KJ/KG AND THE MR EXAMINATION ROOM TEMPERATURE WAS ABOVE THE SPECIFIED VALUE. INVESTIGATION CONCLUDES THAT THE REPORTED EVENT IS MOST LIKELY ATTRIBUTED TO USE ERROR. RELATED WARNINGS CAN BE FOUND IN THE INSTRUCTIONS FOR USE SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

MULTIPLE EFFORTS HAVE BEEN MADE TO GET THE PRODUCT BACK FROM THE CUSTOMER; HOWEVER, IT HAS BEEN UNSUCCESSFUL. THEREFORE, AN INVESTIGATION HAS BEEN COMPLETED BASED ON THE AVAILABLE INFORMATION INCLUDING PHOTOGRAPHIC EVIDENCE AND LOG FILES. IT WAS REPORTED THAT A MALE PATIENT WAS POSITIONED HEADFIRST PRONE AND EXAMINED FOR A RIGHT ELBOW WITH THE SENSE KNEE COIL. THE KNEE COIL IS NOT RECOMMENDED FOR AN ELBOW EXAMINATION. BASED ON THE PROVIDED INFORMATION AND TEST PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL USED. THE INJURY ON THE LEFT FOREARM IS CONSISTENT WITH PATIENT HEATING CAUSED BY CLOSE PROXIMITY TO THE COIL CABLE WHICH LEADS TO AN RF LOOP. THE RF LOOP WAS CREATED BY THE BODY AND THE COIL CABLE. THE POINT WHERE THE LOOP CLOSES, IS THE PLACE OF CABLE-TO-SKIN CONTACT AND THE PLACE OF INJURY. THE COIL CABLE CAN STILL HAVE A NORMAL TEMPERATURE. THE FACT THAT THE INJURY WORSENED OVER TIME, CONFIRMS THAT IT IS AN RF BURN. FOR THE INJURY ON THE INSIDE OF THE RIGHT ELBOW NO DEFINITE CAUSE COULD BE DETERMINED. THE FOLLOWING FACTORS WERE OBSERVED THAT CAN EXPLAIN THE HEATING AS EXPERIENCED BY THE PATIENT AND MAY HAVE CONTRIBUTED TO THE INJURIES: 11 SCANS ON HIGH SAR VALUE WERE ADMINISTERED AND A TOTAL WHOLE-BODY RF DOSE OF 6,9 KJ/KG AND THE MR EXAMINATION ROOM TEMPERATURE WAS ABOVE THE SPECIFIED VALUE. INVESTIGATION CONCLUDES THAT THE REPORTED EVENT IS MOST LIKELY ATTRIBUTED TO USE ERROR. RELATED WARNINGS CAN BE FOUND IN THE INSTRUCTIONS FOR USE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3. NOT EVALUATED REASON: MULTIPLE EFFORTS HAVE BEEN MADE TO GET THE PRODUCT BACK; HOWEVER, IT HAS BEEN UNSUCCESSFUL. INVESTIGATION COMPLETED BASED ON KNOWN INFORMATION.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem

PHILIPS RECEIVED A REPORT FROM A CUSTOMER RELATED TO A PATIENT HEATING INCIDENT WITH A SENSE KNEE COIL 1.5T 8 CH. A PATIENT WAS SCANNED FOR AN MRI EXAMINATION OF THE RIGHT ELBOW. AFTER THE EXAMINATION REDDENING OF THE SKIN AND BLISTERS ON THE LEFT FOREARM / ELBOW AND ON THE INSIDE OF THE RIGHT ELBOW WERE OBSERVED.