BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1633301 · Received March 10, 2010

    Report

    Report Number
    1633301
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 10, 2010
    Manufacturer
    STELLATE SYSTEMS
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE, SMOKE WAS NOTED TO BE COMING FROM THE BACK OF THE EEG MACHINE. OUR BIOMEDICAL ENGINEERING DEPARTMENT DETERMINED THE SOURCE OF THE PROBLEM TO BE A CAPACITOR IN THE POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EEG GWQ STELLATE SYSTEMS HARMONIE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES