BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 553587 · Received November 4, 2004

    Report

    Report Number
    1121732-2004-00017
    Event Type
    Other
    Date Received
    November 4, 2004
    Date of Event
    October 1, 2004
    Report Date
    November 4, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMOKE WAS OBSERVED FROM THE NORTH WALL INTERFACE OF A GIRAFFE INCUBATOR AFTER THE HUMIDITY SETTINGS HAD BEEN CHANGED. AN INFANT WAS BEING TREATED IN THE UNIT WHEN THE EVENT OCCURRED. THE INFANT WAS REMOVED FROM THE UNIT AND TRANSFERRED TO ANOTHER INCUBATOR. THE UNIT WAS TAKEN OUT OF SERVICE AND QUARANTINED AT THE HOSPITAL. THE FIELD SERVICE ENGINEER REPLACED THE RELAY BOARD AND THE UNIT WAS PUT BACK INTO SERVICE THE SAME DAY. NO PT INJURY WAS REPORTED. PRIOR TESTING BY OHMEDA MEDICAL HAS DEMONSTRATED THAT SMOKE CANNOT ENTER THE INFANT COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE INCUBATOR INFANT THERMOREGULATION FMT OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other