SENSE NV COIL 1.5T (16CH)

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

A FEMALE PATIENT WAS POSITIONED HEAD FIRST, SUPINE BEING SCANNED FOR A LOWER SPINE WHERE THE LIGHT VISOR WAS CENTERED OVER LOWER SPINE. PATIENT WAS LAY ON A SENSE SPINE COIL 1.5T IN COMBINATION WITH A SENSE NV COIL 1.5T. PATIENT CAME IN CONTACT WITH THE BALUN OF THE SENSE NV COIL WHICH HAD BECOME HOT TO THE TOUCH (UNKNOWN TEMP). PATIENT EXPERIENCED A BURN OF WHAT APPEARS TO BE APPROXIMATELY 2.5CM.

Additional Manufacturer Narrative

THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION THA TA FEMALE PATIENT WAS POSITIONED HEAD FIRST, SUPINE BEING SCANNED FOR A LOWER SPINE WHERE THE LIGHT VISOR WAS CENTERED OVER LOWER SPINE. PATIENT WAS LAY ON A SENSE SPINE COIL 1.5T IN COMBINATION WITH A SENSE NV COIL 1.5T. PATIENT CAME IN CONTACT WITH THE BALUN OF THE SENSE NV COIL WHICH HAD BECOME HOT TO THE TOUCH (UNKNOWN TEMP). PATIENT EXPERIENCED A BURN OF WHAT APPEARS TO BE APPROXIMATELY 2.5CM. ADDITIONAL INFORMATION HAS BEEN UPDATED AND THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE FOLLOWING SECTIONS WERE UPDATED: D9, H2, H3, AND H6. CONCLUSION: FROM THE INFORMATION PROVIDED AND THE TESTS PERFORMED IT IS OBSERVED THAT THE SURFACE TEMPERATURE OF THE BALUN DID EXCEED THE CASUAL CONTACT TEMPERATURE 51 C. HOWEVER, BALUN DID NOT FAIL CATASTROPHICALLY IN THE CASES TESTED IN INVIVO. IT SHOULD BE NOTED THAT THE SURFACE TEMPERATURE OF THE SPINE COIL WHERE THE PATIENT SHOULD HAVE BEEN CORRECTLY POSITIONED DID NOT EXCEED THE 41C SPECIFICATION. THE PATIENT INJURY COULD HAVE BEEN AVOIDED IF THE CABLE WOULD HAVE BEEN ROUTED CORRECTLY AS INSTRUCTED IN THE IFU. MOVING FORWARD, MORE COMPLAINTS ABOUT THIS COIL MUST BE MONITORED TO MAKE SURE THAT THIS FAILURE IS AN ANOMALY. 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

CONCLUSION: FROM THE INFORMATION PROVIDED AND THE TESTS PERFORMED IT IS OBSERVED THAT THE SURFACE TEMPERATURE OF THE BALUN DID EXCEED THE CASUAL CONTACT TEMPERATURE 51 C. HOWEVER, BALUN DID NOT FAIL CATASTROPHICALLY IN THE CASES TESTED IN INVIVO. IT SHOULD BE NOTED THAT THE SURFACE TEMPERATURE OF THE SPINE COIL WHERE THE PATIENT SHOULD HAVE BEEN CORRECTLY POSITIONED DID NOT EXCEED THE 41C SPECIFICATION. THE PATIENT INJURY COULD HAVE BEEN AVOIDED IF THE CABLE WOULD HAVE BEEN ROUTED CORRECTLY AS INSTRUCTED IN THE IFU. MOVING FORWARD, MORE COMPLAINTS ABOUT THIS COIL MUST BE MONITORED TO MAKE SURE THAT THIS FAILURE IS AN ANOMALY. 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.