BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCHA NEPTUNE

    MDR report key: 1982775 · Received February 4, 2011

    Report

    Report Number
    1982775
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 26, 2011
    Manufacturer
    HUDSON, RCI.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHEN RT DID ROUNDS ON THE PATIENT, NOTICED A BURNING PLASTIC SMELL, FELT THE COMFORT FLOW CIRCUIT IT WAS EXTREMELY HOT TO THE TOUCH, THE WATER IN THE COLUMN WAS ALSO VERY HOT, RT NOTICED THAT THE TEMP PROBE HAD BECOME DISCONNECTED TO THE WATER COLUMN, RT IMMEDIATELY DISCONNECTED THE CIRCUIT FROM THE BABY'S CANNULA. THE CANNULA WAS NOT HOT AND THE POINT AT WHICH THE CANNULA AND CIRCUIT WERE CONNECTED WAS NOT HOT. RT CHANGED THE CIRCUIT DUE TO THE PROBLEM, RECONNECTED ALL PROBES, PLACED BACK ON INFANT. RT LEFT THE HEATER OFF FOR APPROX 1 HOUR SO, THAT IT COULD COOL DOWN. HEATER / HUMIDIFIER DID NOT ALARM AT OVERTEMP WHEN SENSOR WAS DISCONNECTED AT WATER COLUMN. DEVICE WAS REMOVED FROM SERVICE AND EVALUATED TO CONFIRM MALFUNCTION. DEVICE DID NOT ALARM ON OVERTEMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCHA NEPTUNE HEATER / HUMIDIFIER BTT HUDSON, RCI. 425-00

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Hospitalization| R