BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 3D

    MDR report key: 21103410 · Received January 8, 2025

    Report

    Report Number
    1220984-2025-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 9, 2024
    Report Date
    February 7, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT 510K IS P080003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURINGA SELENIA DIMENSIONS PROCEDURE, THE CUSTOMER REPORTED THAT THE ENTIRE GANTRY WAS SHAKING. A FULL SYSTEM REBOOT WAS PERFORMED BUT IT CONTINUED TO SHAKE. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND HE PROCEEDED TO TIGHTEN THE GROUND STRAPS ON THE VTA, AND TIGHTEN THE VTA BOLTS. THE TOMO WAS ADJUSTED AND CALIBRATED. THE SYSTEM WAS NO LONGER JERKING. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105294 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC SDM-05000-3D3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown