BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCHATHERM NEPTUNE

    MDR report key: 1999606 · Received February 14, 2011

    Report

    Report Number
    1999606
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 14, 2011
    Manufacturer
    TELEFLEX INC
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UPPER MIDDLE PART OF THE HIGH FLOW CIRCUIT MELTED AND STUCK TO BED LINEN. THE HUMIDIFIER DID NOT ALARM; TEMPERATURE READING 28 DEGREES CELSIUS; CIRCUIT FELT HOT TO THE TOUCH (FELT HOTTER THAN 37 DEGREES C). CONDENSATION NOTED BELOW THE MELTED PART OF CIRCUIT; VERY LITTLE CONDENSATION NOTED ABOVE IT. DETACHED HIGH FLOW CIRCUIT FROM THE NSALA CANNULA AND UNPLUGGED POWER PLUG OF NEPTUNE HUMIDIFIER. ADMINISTERED 02 BLOW BY VIA BAG AND MASK; PATIENT SAT SATURATION RECOVERED. THE MELTED CIRCUIT HAD BEEN IN USE FOR APPROXIMATELY 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCHATHERM NEPTUNE HEATED HUMIDIFIER BTT TELEFLEX INC * *
    2 HEATED WIRE CIRCUIT HEATED WIRE CIRCUIT OFP TELEFLEX INC HUDSON RCI * *
    3 CONCHA COLUMN CONCHA COLUMN BTT TELEFLEX INC HUDSON RCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *