BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING ARM FOR CEILING MOUNT SYSTEM

    MDR report key: 491920 · Received October 21, 2003

    Report

    Report Number
    2411512-2003-00012
    Event Type
    Malfunction
    Date Received
    October 21, 2003
    Date of Event
    September 17, 2003
    Report Date
    September 17, 2003
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEILING ARTICULATING ARM HAD BROKEN AND FELL TO THE FLOOR WITH THE INJECTOR ATTACHED, BRUISING THE TECHNICIAN'S RIGHT HAND. THE ARM CRACKED AT THE JUNCTION WHERE THE ARTICULATING ARM SLIDES ON THE ROUND SHAFT OF THE DOWN COLUMN ROD. A LOANER INJECTOR WAS INSTALLED BY E-Z-EM AND THE CUSTOMER'S UNIT WAS RETURNED FOR EVALUATION.

    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 010103833113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PERCUPUMP WITH EDA INJECTOR SYSTEM MANUFACTURED BY| E-Z-EM, INC. (CATALOG NO. 8805).