BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR SHIELDS ISOLETTE INFANT INCUBATOR

    MDR report key: 1588235 · Received January 14, 2010

    Report

    Report Number
    2510954-2010-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 20, 2009
    Report Date
    January 14, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMZ
    PMA / PMN Number
    K912910
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE STILL INVESTIGATING THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS WE COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS ISOLETTE INFANT INCUBATOR INFANT INCUBATOR FMZ DRAGER MEDICAL SYSTEMS, INC. (PNC) C100QT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK