BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILET

    MDR report key: 1437410 · Received August 13, 2009

    Report

    Report Number
    2510954-2008-00002
    Event Type
    Injury
    Date Received
    August 13, 2009
    Date of Event
    January 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL # P1251-B. THE STABILET INFANT WARMER AND BASSINET SYSTEM WERE MANUFACTURED BY HILL-ROM. THROUGH ACQUISITION, DRAEGER MEDICAL SYSTEMS INC. (DMSI) HAS REPORTING RESPONSIBILITIES FOR THE STABILET PRODUCT LINE. THE DEVICE IS CURRENTLY UNDER EVAL BY THE USER FACILITY. DMSI HAS NOT BEEN GIVEN ACCESS TO EVALUATE THE DEVICE. IF DMSI IS GIVEN THE OPPORTUNITY TO EVALUATE THE DEVICE, AN ADDITIONAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PT WAS INJURED WHEN OXYGEN INSIDE AN OXYGEN HOOD IGNITED. THE PT WAS LYING IN A BASSINET UNDER A STABILET WARMER AT THE TIME OF THE REPORTED INCIDENT. VARIOUS OTHER DEVICES WERE ALSO IN USE. THE FIRE WAS EXTINGUISHED AND THE NEWBORN WAS TRANSFERRED TO THE BURN UNIT AT ANOTHER FACILITY. AS OF EARLY 2008, THE NEWBORN WAS IN CRITICAL, BUT STABLE, CONDITION AND HAD SUFFERED SECOND AND THIRD DEGREE BURNS ON 17 TO 18 PERCENT OF HIS BODY, INCLUDING HIS HEAD, SHOULDERS, PART OF HIS FACE, AND THE TOPS OF HIS HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILET INFANT WARMER AND BASSINET SYSTEM FMT DRAGER MEDICAL SYSTEMS, INC. (PNC) P1250-A 694080

    Patients

    Seq Age Sex Outcome Treatment
    1 12 HR Required Intervention OXYGEN HOOD