BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRILLIANCE CT SCANNER 40 SLICE CONFIGURATION

    MDR report key: 828762 · Received March 14, 2007

    Report

    Report Number
    1525965-2007-00002
    Event Type
    Death
    Date Received
    March 14, 2007
    Date of Event
    February 7, 2007
    Report Date
    March 13, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECORDS DO NOT INDICATE ANY ANOMALOUS BEHAVIOR ON THE SYSTEM AT THE SITE. THE SYSTEM IS CURRENTLY CLINICALLY OPERATIONAL. PRELIMINARY TESTING AT THE FACTORY, BASED ON THE INFO PROVIDED, IS THAT THE SYSTEM OPERATED AS DESIGNED. PHILIPS WILL CONTINUE TO INVESTIGATE THE EVENT FURTHER. PHILIPS HAS SUGGESTED TO THE CUSTOMER THAT CLINICAL APPLICATIONS PERSONNEL SHOULD VISIT THE SITE TO REVIEW PT POSITIONING AND SCAN INITIALIZATION, AND TRY TO REPLICATE THE EVENT SO THAT THE SYSTEM MESSAGES CAN BE REVIEWED.

    Description of Event or Problem · 1

    THE SITE ATTEMPTED TO SCAN A TRAUMA PT. THE SITE STATES THAT THERE WERE NO PROBLEMS WHILE LOWERING AND RAISING THE TABLE AND POSITIONING THE PT FOR THE SURVIEW (POSITIONING) SCAN. THE TECHNOLOGISTS CHOSE THE TRAUMA PROTOCOL AND PUSHED "GO" FOR THE SURVIEW (POSITIONING) SCAN. THE SYSTEM STARTED TO EXECUTE ITS INITIALIZATION SEQUENCE AND THE TABLE STARTED SLOWLY TO MOVE INTO START POSITION FOR THE SURVIEW. DURING THIS TIME, TWO ERROR MESSAGES WERE DISPLAYED. THE TECHNOLOGISTS UNFORTUNATELY DO NOT REMEMBER THE ERRORS THAT CAME UP ON THE SCREEN. THEY STOPPED THE EXAMINATION AND STARTED A NEW ONE WHERE THEY CHOOSE CURRENT PT. THEY POSITIONED THE TABLE AGAIN AS BEFORE AND THEY GOT THE SAME ERROR MESSAGES. THEN THEY LOGGED OUT AND LOGGED IN AGAIN AND STARTED FROM THE BEGINNING WITH A NEW EXAMINATION, WITH THE SAME RESULT. THE PT WAS REMOVED FROM THE TABLE AND DURING THE PROCESS OF TRANSPORTATION TO ANOTHER SCANNER, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE CT SCANNER 40 SLICE CONFIGURATION COMPUTED TOMOGRAPHY SYSTEM JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728235 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other