BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 640344 · Received August 26, 2005

    Report

    Report Number
    1121732-2005-00016
    Event Type
    Malfunction
    Date Received
    August 26, 2005
    Date of Event
    July 4, 2005
    Report Date
    August 25, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY NOTED THE PATIENT'S SKIN BECAME REDDENED. THERE WAS NO REPORTED PATIENT INJURY. OHMEDA MEDICAL'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    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 2 DAY