BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRIS ALLURA 15 - 12

    MDR report key: 1132323 · Received August 20, 2008

    Report

    Report Number
    1217116-2008-00059
    Event Type
    Death
    Date Received
    August 20, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 19, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THIS X-RAY EXAM, THE PT TABLE WAS IN THE HORIZONTAL POSITION. THE DR ACCIDENTALLY HIT THE TILT BUTTON AND THE TABLE WENT TO +2 DEGREES. HE THEN HIT THE MUSHROOM SWITCH TO STOP THE TABLE, BUT INSTEAD THE TABLE DROVE ALL THE WAY TO THE HEAD END OF TABLE, STOPPED, AND THEN THE GEOMETRY SUBSYSTEM RESET. THE OPERATOR WAS UNABLE TO GET THE GEOMETRY SUBSYSTEM BACK ON LINE. PT WENT INTO CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 15 - 12 IZI (ANGIOGRAPHIC X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS 722044 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death