BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABINET, X-RAY SYSTEM

    MDR report key: 7224815 · Received January 29, 2018

    Report

    Report Number
    7224815
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    September 15, 2017
    Report Date
    January 17, 2018
    Manufacturer
    FAXITRON BIOPTICS, LLC
    Product Code
    MWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIOMEDICAL ENGINEERING DEPARTMENT RECEIVED A CALL THAT THE FAXITRON BIOVISION WAS LOCKED UP. IMAGING ENGINEER WENT DOWN THE OR TO INVESTIGATE. UPON ARRIVING THE IMAGING ENGINEER WITNESS THE DEVICE WAS LOCKED UP. THE ENGINEER WENT TO INVESTIGATE THE LOG FILES AND FOUND OUT THAT SOMEONE HAD DOWNLOADED MUSIC AND WAS USING THE SYSTEMS INTERNET SERVICE TO ACCESS THE MUSIC. ONCE THE DEVICE WAS RESET, THE SYSTEM WAS ABLE TO BOOT BACK UP PROPERLY AND WAS TESTED AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69175 CABINET, X-RAY SYSTEM MWP FAXITRON BIOPTICS, LLC BIOVISION

    Patients

    Seq Age Sex Outcome Treatment
    1