BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRILLIANCE AIR 40/64/UCT

    MDR report key: 6875814 · Received September 19, 2017

    Report

    Report Number
    1525965-2017-00018
    Event Type
    Death
    Date Received
    September 19, 2017
    Report Date
    September 7, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, THE CUSTOMER REPORTED AN (B)(6)-YEAR OLD FEMALE ARRIVED AT THE FACILITY AFTER A TRAUMATIC AUTOMOBILE ACCIDENT. THE PATIENT WAS BROUGHT TO THE CT SCAN ROOM FOR AN IMAGING PROCEDURE. PRIOR TO THE SURVIEW, AND WHILE THE CT SYSTEM WAS INITIALIZING, A SCAN ABORT ERROR OCCURRED HALTING THE CT IMAGING PROCEDURE. THE OPERATOR PERFORMED A CT SYSTEM RESTART AND WAS ABLE TO SUCCESSFULLY CONTINUE WITH THE CT IMAGING PROCEDURE. THE OPERATOR SUCCESSFULLY COMPLETED THE SURVIEW, BRAIN SCAN, AND CERVICAL SPINE SCAN AS PLANNED. AFTER COMPLETION OF THE CERVICAL SPINE SCAN, THE PATIENT BECAME UNSTABLE AND REQUIRED IMMEDIATE MEDICAL INTERVENTION. THE MEDICAL STAFF ATTEMPTED TO RESUSCITATE THE PATIENT WHILE ON THE CT COUCH. ULTIMATELY THE RESUSCITATION ATTEMPT WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. THIS OCCURRED ON AN INGENUITY CORE CT SYSTEM. THE PHILIPS SERVICES DELIVERY MANAGER (SDM) CONFIRMED THAT THE SCAN ABORT ISSUE WAS INTERMITTENT IN NATURE AND WAS THE RESULT OF TUBE ARCING DUE TO A THREAD BEING DAMAGED ON THE HIGH VOLTAGE PLUG AND X-RAY TUBE CONNECTOR. THE SDM CONFIRMED THAT PHILIPS SERVICE REPLACED THE X-RAY TUBE, AND HIGH VOLTAGE CABLE TO RESOLVE THE INTERMITTENT X-RAY TUBE ARCING ISSUE. THE X-RAY TUBE ARCING AND PART REPLACEMENT IS ADDRESSED BY (B)(4). THE SDM AND A TRAUMA SURGEON, WHO WAS ON CALL AT THE TIME OF THIS INCIDENT, CONFIRMED THAT THE PATIENT EXPIRED AS A RESULT OF THE TRAUMATIC INJURIES SUFFERED DURING THE AUTOMOBILE ACCIDENT WHICH OCCURRED PRIOR TO THE PATIENT ARRIVING AT THE MEDICAL FACILITY. THE TRAUMA SURGEON CONFIRMED THAT IN NO WAY DID THE PHILIPS INGENUITY CORE CT SYSTEM CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. THERE WAS NO MALFUNCTION OF THE CT SYSTEM; THE SYSTEM IS WORKING AS SPECIFIED. THIS COMPLAINT IS NO LONGER CONSIDERED A REPORTABLE EVENT. THE SYSTEM IS IN CLINICAL USE.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT WHEN AN UNSTABLE PATIENT WAS ON THE CT SYSTEM, A SCAN ABORT OCCURRED. THE PATIENT WAS UNSTABLE (CRITICAL CONDITION) DUE TO BEING INVOLVED IN A SERIOUS MOTOR VEHICLE ACCIDENT PRIOR TO ARRIVING IN THE EMERGENCY DEPARTMENT. A RESTART OF THE SYSTEM WAS PERFORMED AND THE SCAN OF THE PATIENT¿S BRAIN AND C-SPINE WERE THEN COMPLETED. WHILE WAITING FOR CONTRAST TO BE INJECTED FOR FURTHER SCANNING, THE PATIENT BECAME MORE UNSTABLE AND EXPIRED WHILE ON THE CT SYSTEM. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657193 BRILLIANCE AIR 40/64/UCT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR