BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFIRM PRONE BIOPSY SYSTEM, 3D

    MDR report key: 11803017 · Received May 10, 2021

    Report

    Report Number
    1220984-2021-00007
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 10, 2021
    Manufacturer
    HOLOGIC, INC
    Product Code
    IZH
    UDI-DI
    15420045506510
    PMA / PMN Number
    K153486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER SMELLED SMOKE WHEN TURNING ON THE MACHINE. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND FOUND A TRANSFORMER WITHIN THE GENERATOR CABINET APPEARED MELTED. THE GENERATOR CABINET AND CABLES TO THE TABLE WERE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698878 AFFIRM PRONE BIOPSY SYSTEM, 3D BREAST BIOPSY SYSTEM IZH HOLOGIC, INC PBX-SYS-AFFIRM-3D 15420045506510

    Patients

    Seq Age Sex Outcome Treatment
    1