BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

    MDR report key: 6940743 · Received October 11, 2017

    Report

    Report Number
    1220984-2017-00068
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 13, 2017
    Report Date
    September 13, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    UDI-DI
    15420045505582
    PMA / PMN Number
    PO10025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE GETTING DETECTOR AND GCB ERRORS. THE FIELD ENGINEER DETERMINED THAT THE DETECTOR WAS DEFECTIVE. ONCE THIS WAS REPLACED THE UNIT IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720238 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM FULL FILED DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC. SDM-00001-2D N/A 15420045505582

    Patients

    Seq Age Sex Outcome Treatment
    1