BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D

    MDR report key: 16064535 · Received December 28, 2022

    Report

    Report Number
    1220984-2022-00105
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 28, 2022
    Manufacturer
    HOLOGIC, INC
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED ON DECEMBER 7TH THAT DURING A SELENIA DIMENSIONS PROCEDURE THE MLO ROTATION DID NOT STOP ROTATION AT 45 DEGREE DETENTS AND WAS SHOWING ERRATIC MOVEMENT. A FIELD ENGINEER EXAMINED THE CONSOLE AND FOUND THAT THE SIDE SWITCHES WERE CAUSING THE ROTATION OF THE C-ARM INTERMITTENTLY AND THE FOOT SWITCHES DID NOT WORK. THE SWITCHES WERE REPLACED AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO HARM TO THE PATIENT OR STAFF REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452961 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC SDM-00001-2D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown