BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUINOX HEATED, HUMIDIFIED, HIGH FLOW OXYGEN NASAL CANNULA DELIVERY SYSTEM

    MDR report key: 1051957 · Received May 22, 2008

    Report

    Report Number
    1217052-2008-00072
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    SMITHS MEDICAL CRITICAL CARE
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATION: HISTORY OF THIS TYPE OF REPORT SHOWS THIS TO LIKELY BE DUE TO THE TUBING BEING CRIMPED OFF DURING THE PATIENT'S BEDDING CHANGE. REVIEW OF THE INSTRUCTIONS FOR USE HAS A WARNING: "DO NOT OCCLUDE ANY PART OF THE DELIVERY CIRCUIT. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO ADD A PRESSURE RELIEF SYSTEM FOR THIS CATALOG NUMBER. SMITHS MEDICAL HAS PERFORMED A RISK ANALYSIS OF THIS ISSUE AND HAS FOUND THE PATIENT RISK TO BE LOW AND THE PROBABILITY OF OCCURRENCE IN POPULATION EXPOSED TO BE REMOTE. THEREFORE, SMITHS MEDICAL BELIEVES THAT THE PRODUCTS IN THE FIELD CAN BE USED SAFELY WHEN THE INSTRUCTION FOR USE AND LABELING ARE FOLLOWED.

    Description of Event or Problem · 1

    USER ALLEGES THREE EVENTS OF USING THE AQUINOX UNIT AND THE PLASTIC CHAMBER BLEW OFF FROM THE METAL HEATER PLATE. NO ADVERSE OUTCOME TO PATIENTS AND NO SPECIFICS GIVEN FOR ANY OF THE THREE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUINOX HEATED, HUMIDIFIED, HIGH FLOW OXYGEN NASAL CANNULA DELIVERY SYSTEM 80 BTT - HUMIDIFIER, RESPIRATORY GAS (DIRECT PATIENT INTERFACE) BTT SMITHS MEDICAL CRITICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1