BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS BH5000

    MDR report key: 1942706 · Received November 29, 2010

    Report

    Report Number
    3003768277-2010-00341
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE INVESTIGATION FOUND THAT THE PROBLEM WAS CAUSED BY A DEFECTIVE CIRCUIT BOARD (BH IGC CARD). THE PROBLEM WAS RESOLVED AFTER ITS REPLACEMENT. BASED ON TRENDING ANALYSIS, THERE IS NO EXCEPTIONAL REPLACEMENT RATE. THERE IS NO REQUIRED FIELD MANDATORY ACTION.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM WOULD NOT FLUORO OR CINE. THERE WERE NO DISPLAYED ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS BH5000 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 72247 NA

    Patients

    Seq Age Sex Outcome Treatment
    1