BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCHATHERM NEPTUNE

    MDR report key: 2140670 · Received June 21, 2011

    Report

    Report Number
    2140670
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    December 17, 2010
    Report Date
    June 21, 2011
    Manufacturer
    TELEFLEX MEDICAL HUDSON RCI
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    SMOKE WAS COMING OUT OF THE VENTILATOR. THE SOURCE OF THE SMOKE WAS THE HEATER WIRE ATTACHED TO THE VENTILATOR CIRCUIT. THE VENTILATOR WAS REMOVED FROM SERVICE. OUR BIOMED BIOMEDICAL ENGINEERING DEPARTMENT WORKED WITH THE MANUFACTURER BUT WE ARE STILL HAVING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCHATHERM NEPTUNE HEATED HUMIDIFIER BTT TELEFLEX MEDICAL HUDSON RCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR