BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 2724197 · Received August 29, 2012

    Report

    Report Number
    1525965-2012-00061
    Event Type
    Death
    Date Received
    August 29, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT WAS POSITIONED ON THE SCANNING TABLE WITH ADD'L EMERGENCY EQUIPMENT AND A VACUUM MATTRESS. THE OPERATOR FIRST PERFORMED A SKULL SCAN WHICH COMPLETED AND RECONSTRUCTED SUCCESSFULLY. THE OPERATOR THEN REPOSITIONED THE TABLE VERTICALLY (HIGHER) FOR THE SECOND SERIES OF THE EXAM (NECK, THORAX, ABDOMEN SCAN). THE OPERATOR STATED THE VERTICAL TABLE MOVEMENT COMPLETED SUCCESSFULLY. WHEN THE OPERATOR ATTEMPTED TO MANUALLY MOVE THE TABLE HORIZONTALLY INTO THE GANTRY, USING THE TABLE CONTROLS ON THE GANTRY PANEL, THERE WAS RHYTHMIC GRINDING NOISES GENERATED BY THE HORIZONTAL TABLE MOTION FOLLOWED BY A "GANTRY CANNOT COMPLY" ERROR THAT APPEARED AND THE TABLE MOVEMENT COULD NO LONGER BE DRIVEN USING THE GANTRY PANEL BUTTONS. AT THAT TIME, THE PT'S CONDITION HAD DETERIORATED; THE OPERATOR MANUALLY PULLED THE TABLE OUT OF THE GANTRY BY USING THE TAPESWITCH, RELEASING THE CLUTCH AND EXTRACTING THE PT. THE HOSP STAFF INITIATED CARDIO-PULMONARY RESUSCITATION, WHICH WAS UNSUCCESSFUL AND THE PT EXPIRED. AFTER THE EXAMINATION WAS FINISHED THE CUSTOMER WAS ABLE TO CONTINUE TO USE THE CT SYSTEM WITHOUT PERFORMING A REBOOT AND WITHOUT ANY LIMITATIONS. THE FIELD SERVICE ENGINEER INSPECTED THE TABLE AND DID NOT FIND ANY ISSUES. LOGFILE ANALYSIS INDICATES THE PT TABLE WAS COMMANDED TO MOVE FROM THE TOUCH PANEL BUT DID NOT MOVE. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO THE TABLE STALLING DUE TO FRICTION/BLOCKED MOVEMENT CAUSED BY THE PT AND ADDED EQUIPMENT ON THE TABLE. AFTER THE OPERATOR MANUALLY RELEASED AND PULLED THE TABLE OUT, THE TABLE WAS RESET AND ELECTRIC MOVEMENT WAS ENABLED AGAIN TO THE GANTRY PANEL.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A CUSTOMER COMPLAINT STATING THAT DURING A CT SCANNING EXAM OF A POLYTRAUMA PT A "GANTRY CANNOT COMPLY ERROR" DISPLAYED ON THE MONITOR AND IT WAS NOT POSSIBLE TO MOVE THE TABLE IN FOR THE SECOND SERIES OF THE EXAM USING THE GANTRY CONTROL PANEL BUTTONS. AT THAT TIME, THE PT'S CONDITION HAD DETERIORATED; THE OPERATOR MANUALLY PULLED THE TABLE OUT OF THE GANTRY AND THE HOSP TEAM INITIATED CARDIO-PULMONARY RESUSCITATION, WHICH WAS UNSUCCESSFUL, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1 Death