BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 754172 · Received October 25, 2005

    Report

    Report Number
    1121732-2005-00018
    Event Type
    Malfunction
    Date Received
    October 25, 2005
    Date of Event
    September 26, 2005
    Report Date
    October 25, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY NOTED A BURN WHERE THE TEMPERATURE PROBE WAS ATTACHED. THE HOSPITAL PERSONNEL REPORTEDLY APPLIED A BURN OINTMENT. THE CUSTOMER FURTHER REPORTED THAT THE BABY WAS PRETERM AND WAS NOTED TO HAVE SENSITIVE SKIN. OHMEDA MEDICAL'S SERVICE REPRESENTATIVES PERFORMED A CHECKOUT OF THE EQUIPMENT, AND IT WAS FOUND TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY