BEUDAMED
    FDA Adverse Event Other Summary report: N

    E2 EM

    MDR report key: 829250 · Received March 12, 2007

    Report

    Report Number
    MW1042228
    Event Type
    Other
    Date Received
    March 12, 2007
    Date of Event
    February 2, 2007
    Report Date
    March 12, 2007
    Manufacturer
    E-Z-EM, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CT AUTOINJECTOR REMOTE AND BASE UNITS LOST CONNECTION WITH EACH OTHER. UNIT POWERED OFF AND TURNED BACK ON. WHEN UNIT CAME UP, IT STARTED INJECTING. CT TECH TRIED TO STOP INJECTING BY ACTIVATING EMERGENCY STOP BUTTON AND UNIT WOULD NOT TURN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E2 EM EMPOWER CTA AUTOINJECTOR DXT E-Z-EM, INC. 9930 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other