BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 1802457 · Received August 9, 2010

    Report

    Report Number
    3003768277-2010-00154
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K050151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    THE USER OF THIS X-RAY SYSTEM IS ALLEGING THAT FOUR TIMES MORE RADIATION IS BEING TRANSMITTED THAN REQUESTED BY OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA KPR (SYSTEM, X-RAY STATIONARY) KPR PHILIPS MEDICAL SYSTEMS 708034 NA

    Patients

    Seq Age Sex Outcome Treatment
    1