BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDONE RF

    MDR report key: 305655 · Received November 17, 2000

    Report

    Report Number
    1318879-2000-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2000
    Date of Event
    October 4, 2000
    Report Date
    November 6, 2000
    Manufacturer
    INFIMED, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FLOUROSCOPIC IMAGING SYSTEM WAS BEING USED TO IMAGE A PT. THE MONITOR IN THE X-RAY ROOM WAS MOUNTED ON AN OVERHEAD UNIT. WHEN THE MONITOR WAS MOVED TO ALLOW IMAGES TO BE VIEWED, THE MONITOR BROKE LOOSE FROM THE BASE AND FALL. IT HIT THE PT ON THE ARM AND A RADIOLOGY TECHNOLOGIST ON THE ARM AND HEAD. INJURIES WERE REPORTED TO BE NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDONE RF FLUOROSCOPIC IMAGING COMPUTER JAA INFIMED, INC. GOLDONE RF

    Patients

    Seq Age Sex Outcome Treatment
    1