BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUEDIAGNOST

    MDR report key: 2190972 · Received July 19, 2011

    Report

    Report Number
    3003768251-2011-00046
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    JAA
    PMA / PMN Number
    K983069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A F/U REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOUD NOISE. THE TUBESTAND MOVED DOWNWARDS TO THE MAXIMUM DOWN ANGLE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUEDIAGNOST JAA PHILIPS MEDICAL SYSTEMS DMC GMBH 707015

    Patients

    Seq Age Sex Outcome Treatment
    1