BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D

    MDR report key: 6853423 · Received September 8, 2017

    Report

    Report Number
    1220984-2017-00024
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER A "SPIRAL SHADE ON IMAGE" WAS FOUND WHICH RESULTED IN THE NEED FOR AN ADDITIONAL EXPOSURE TO COMPLETE THE EXAM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHICH REVEALED NO DUST OR FOREIGN THINGS WERE NOT FOUND IN THE FILTER, COLLIMATOR AND FPD GRID. THE SOFTWARE WAS REVISED AND THE IMAGE WAS NEWLY UPLOADED AND NO SYMPTOMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632313 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC SDM-00001-3D NA

    Patients

    Seq Age Sex Outcome Treatment
    1