BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D

    MDR report key: 6902563 · Received September 28, 2017

    Report

    Report Number
    1220984-2017-00046
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 9, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OTE
    PMA / PMN Number
    PO80003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS MDR IS A RESUBMIT PER REQUEST OF (B)(6) WHICH WAS RECEIVED BY HOLOGIC, INC. ON JULY 28TH 2020. IT WAS REPORTED THAT THEY WERE GETTING ERROR CODES, WHICH CAUSED THE IMAGE TO BE REPEATED. THE UNIT WAS OUT OF TOLERANCE, THE FE CALIBRATED THE SYSTEM AND IT'S WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682801 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC. SDM-050000-3DC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown