BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H5000

    MDR report key: 1872917 · Received October 5, 2010

    Report

    Report Number
    3003768277-2010-00235
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM'S GENERATOR MALFUNCTIONED (NOT AVAILABLE) DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS H5000 IZI (SYSTEM, X-RAY, ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 72246 NA

    Patients

    Seq Age Sex Outcome Treatment
    1