BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

    MDR report key: 15229855 · Received August 15, 2022

    Report

    Report Number
    1220984-2022-00071
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 21, 2022
    Report Date
    August 15, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MACHINE SPONTANEOUSLY TURNED 180 DEGREES WHILE ANGLING FOR AN MLO VIEW AND GAVE AN ERROR CODE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE C-ARM SWITCHES NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541835 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC. SDM-00001-2D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown