BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C100 INCUBATOR

    MDR report key: 1578386 · Received January 11, 2010

    Report

    Report Number
    MW5014324
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 20, 2009
    Report Date
    January 11, 2010
    Manufacturer
    DRAGER MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2009, WHILE A PT WAS IN THE C100 INCUBATOR, THE STAFF OBSERVED SMOKE COMING FROM THE INCUBATOR. THE STAFF IMMEDIATELY REMOVED THE PT FROM THE INCUBATOR AND MOVED THE INCUBATOR INTO THE HALLWAY. NO PT OR STAFF INJURY WAS REPORTED. THE UNIT WAS SHIPPED BY DRAGER TO THEIR IN-HOUSE TECHNICAL STAFF FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C100 INCUBATOR NONE FMZ DRAGER MEDICAL C100

    Patients

    Seq Age Sex Outcome Treatment
    1