BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA MAMMOGRAPHY SYSTEM

    MDR report key: 7168869 · Received January 5, 2018

    Report

    Report Number
    1220984-2018-00027
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 8, 2017
    Report Date
    December 8, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    PMA / PMN Number
    PO10025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE GETTING AN MIV ERROR 22 DURING PATIENT EXPOSURE, RESULTING IN THE PATIENT HAVING TO HAVE EXPOSURE REPEATED. THE CUSTOMER RESTARTED THE UNIT ONCE THIS WAS DONE THE UNIT IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11390 SELENIA MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC. SEL-00023 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1