BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING ARM FOR CEILING MOUNT SYSTEM

    MDR report key: 377488 · Received February 14, 2002

    Report

    Report Number
    2432460-2002-00003
    Event Type
    Malfunction
    Date Received
    February 14, 2002
    Date of Event
    January 14, 2002
    Report Date
    January 15, 2002
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ARTICULATING ARM BROKE CAUSING THE INJECTOR TO FALL TO THE FLOOR. THE BROKEN ARM WAS FOUND BY THE CT TECHNOLOGIST. THE INJECTOR HEAD WAS IN OKAY CONDITION AND WAS REMOUNTED ONTO A FLOOR STAND PROVIDED BY E-Z-EM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATING ARM FOR CEILING MOUNT SYSTEM CT INJECTOR ACCESSORY FIH E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA