BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRIS BH3000

    MDR report key: 1132943 · Received August 22, 2008

    Report

    Report Number
    1217116-2008-00064
    Event Type
    Death
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS HAVING AN X-RAY PROCEDURE. THE FLUORO SYSTEM WENT DOWN WHEN THE X-RAY TECH STEPPED ON THE FLUORO PEDAL. THE FLUORO SYSTEM WOULD NOT REBOOT. THEN THE C-ARM WAS REQUESTED AS A BACKUP, SINCE THE PT COULD NOT BE MOVED DUE TO HER CRITICAL CONDITION. HOWEVER, THE PT RAPIDLY DECOMPENSATED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS BH3000 IZI (SYSTEM, X-RAY, ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 72242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death