BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOBE-TROTTER NEONATAL TRANSPORT SYSTEM

    MDR report key: 938043 · Received November 2, 2007

    Report

    Report Number
    2510954-2007-00004
    Event Type
    Other
    Date Received
    November 2, 2007
    Date of Event
    September 25, 2007
    Report Date
    November 1, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, (PNC)
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THIS INCIDENT TO THE SERVICE ENGINEER OF OUR DISTRIBUTOR IN ANOTHER COUNTRY. OUR DISTRIBUTOR WILL CONDUCT AN ONSITE EVALUATION, AND WE WILL ISSUE A FOLLOW-UP REPORT WHEN WE CONCLUDE OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE MACHINE WAS USED IN THE NICU DEPT AND AFTER THE PT WAS REMOVED, THEY PLUGGED THE INCUBATOR INTO AN AC SOURCE. FIVE MINUTES AFTER BEING PLUGGED IN, IT STARTED TO EMIT SMOKE FROM THE PNEUMATIC MODULE, AND THEN CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBE-TROTTER NEONATAL TRANSPORT SYSTEM NEONATAL TRANSPORT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, (PNC) GT500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR