BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRSHIELDS

    MDR report key: 674200 · Received January 30, 2006

    Report

    Report Number
    674200
    Event Type
    Other
    Date Received
    January 30, 2006
    Date of Event
    October 6, 2005
    Report Date
    January 30, 2006
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    FMZ
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT IN ISOLETTE SET AT 26 DEGREES CELSIUS. ISOLETTE WAS UNPLUGGED FOR TRANSFER OF INFANT AND UNIT RESET TO 35 DEGREES CELSIUS WHEN PLUGGED BACK IN. INFANT NOTED TO BE TACHYPNEIC AND TACHYCARDIC WITH AXILLARY TEMPERATURE OF 38.5. STAFF UNAWARE OF AUTOMATIC RESET TO 35 DEGREES WHEN THERE IS LOSS OF POWER OR UNIT IS UNPLUGGED. THE UNIT WILL STORE THE SET TEMPERATURE FOR A 15 MINUTE PERIOD BEFORE DEFAULT TO 35 DEGREES CELSIUS. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS INCUBATOR FMZ DRAEGER MEDICAL, INC. C-2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DA