BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTICARE PLATNIUM

    MDR report key: 7155421 · Received December 29, 2017

    Report

    Report Number
    1220984-2017-00296
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    PMA / PMN Number
    KO30666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY ARE GETTING ARTIFACTS IN THE IMAGES, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THERE WAS A BAD FUSE IN THE POWER SUPPLY. ONCE THIS WAS REPLACED THE UNIT IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934662 MULTICARE PLATNIUM STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC, INC. 8-004-0017 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1