BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFIRM PRONE BIOPSY SYSTEM, 3D

    MDR report key: 7155131 · Received December 29, 2017

    Report

    Report Number
    1220984-2017-00293
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 1, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZH
    UDI-DI
    15420045506510
    PMA / PMN Number
    K153486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE GETTING GREY AND WASHED OUT IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. THEY REBOOTED THE SYSTEM AND WERE ABLE TO GET GOOD IMAGES. SINCE THE REBOOT OF THE SYSTEM THEY HAVE HAD NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933795 AFFIRM PRONE BIOPSY SYSTEM, 3D BREAST BIOPSY SYSTEM IZH HOLOGIC, INC. PBX-SYS-AFFIRM-3D N/A 15420045506510

    Patients

    Seq Age Sex Outcome Treatment
    1