BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INTENSIVE CARE SYSTEM

    MDR report key: 1689958 · Received May 12, 2010

    Report

    Report Number
    2510954-2010-00006
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    February 22, 2010
    Report Date
    April 12, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K875270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAGER HAS REQUESTED THE PART FOR INVESTIGATION. WE ARE STILL INVESTIGATING THIS REPORTED INCIDENT. WE WILL SUBMIT A F/U REPORT AS SOON AS WE COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    AT 1800 HOURS THE INFANT WARMER IN THE NEWBORN NURSERY STARTED SMOKING. THERE WAS NO BABY IN THE WARMER, BUT THERE WERE OTHER BABIES IN THE NURSERY. AFTER SEEING THE SMOKE COMING OUT OF THE TOP OF THE WARMER, IT WAS NOTICED THAT THERE WAS A SMALL FLAME POPPING OUT OF THE UPPER VENT HOLES. THE WARMER WAS UNPLUGGED. THE FLAMES AND SMOKING STOPPED. THE WARMER WAS PUSHED OUT INTO THE HALL. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTENSIVE CARE SYSTEM INFANT WARMER FMT DRAGER MEDICAL SYSTEMS, INC. (PNC) 7880 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK