BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN ANALYZER

    MDR report key: 1003785 · Received February 25, 2008

    Report

    Report Number
    1722070-2008-00001
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MAXTEC, INC.
    Product Code
    CCL
    PMA / PMN Number
    K911344
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION FOR THIS REPORT IS FROM USER FACILITY. EVENT WAS UNKNOWN TO MAXTEC, UNTIL USER FACILITY FAXED A COPY OF THE MDR TO US ON 02/01/2008. THE PRODUCT HAS NOT BEEN ANALYZED YET. SALES REPRESENTATIVE FROM MAXTEC, WAS ALLOWED TO VIEW PRODUCT AND TAKE PICTURES; IN APPROXIMATELY TWO WEEKS MAXTEC ENGINEERS WILL BE ALLOWED TO VIEW PRODUCT IN USER FACILITY, AND ANALYZE PRODUCT.

    Description of Event or Problem · 1

    INFANT PATIENT WAS RESTING IN A BASSINET UNDER AN INFANT WARMER WITH AN OXYGEN HOOD IN PLACE. OXYGEN HOOD WAS PLACED OVER THE INFANT'S HEAD AND WAS ATTACHED TO AN OXYGEN AIR BLENDER FOR ADMINISTRATION OF 100% OXYGEN. AS THE STAFF APPROACHED THE BASSINET, THEY OBSERVED A FLASH OF FLAMES UNDER THE OXYGEN HOOD. STAFF REMOVED HOOD AND REMOVED OXYGEN FROM THE WALL. STAFF USED A BLANKET TO EXTINGUISH THE FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN ANALYZER OM25AE CCL MAXTEC, INC. OM25AE GC0228991

    Patients

    Seq Age Sex Outcome Treatment
    1 12 HR Hospitalization| L| R