BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVIRON-MATE

    MDR report key: 5839471 · Received August 2, 2016

    Report

    Report Number
    5839471
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    May 31, 2016
    Report Date
    July 11, 2016
    Manufacturer
    M D TECHNOLOGIES, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GI LAB DECONTAMINATION ROOM EMPLOYEES BEGAN USING A WALL-MOUNTED ENVIRON-MATE SUCTION-DRAIN SYSTEM DM-6000 DISPOSAL DEVICE LOCATED ON THE WALL NEXT TO THE SCOPE DECONTAMINATION AREA. UPON TURNING ON THE DEVICE, IT BEGAN TO EMIT BLUE SPARKS AND SMOKE. AFTER IMMEDIATELY REALIZING THE DEVICE WAS ON FIRE, THE GI LAB EMPLOYEES INITIATED THE RACE PROCESS BY EVACUATING THE ROOM, CLOSING ALL DOORS, ALERTING THE STAFF, AND CALLING 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492410 ENVIRON-MATE BOTTLE, COLLECTION, VACUUM KDQ M D TECHNOLOGIES, INC. DM-6000

    Patients

    Seq Age Sex Outcome Treatment
    1