BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIDIAGNOST ELEVA

    MDR report key: 1802474 · Received August 11, 2010

    Report

    Report Number
    3003768277-2010-00156
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K032046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD, RESULTS AND CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM HAD A MEASURED ENTRANCE DOSE LIMITATION (EDL) EXCEEDING 10R. THE MAXIMUM MEASURED PT DOSE RATE WAS 21R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIDIAGNOST ELEVA IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 708027 NA

    Patients

    Seq Age Sex Outcome Treatment
    1