BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 4292380 · Received December 2, 2014

    Report

    Report Number
    9611451-2014-00897
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    October 10, 2014
    Report Date
    November 5, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ONE OF THE CHAMBER PORTS WAS DEFORMED. THE MR290V CHAMBER WAS SET UP WITH AN MR850 HUMIDIFIER AND HUMMING V VENTILATOR. THE CUSTOMER HAS CONFIRMED THAT THE POWER TO THE FLOW SOURCE WAS TURNED OFF WHILST THE HUMIDIFIER WAS KEPT ON. THE SETUP ALSO INCLUDED AN IMPEDANCE VALVE ON ONE OF THE CHAMBER PORTS. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 140305. CONCLUSION: THE DEFORMATION OF THE PORT MOST LIKELY OCCURRED DUE TO THE FLOW SOURCE BEING TURNED OFF WHILST THE HUMIDIFIER WAS KEPT ON. THE USER INSTRUCTIONS WERE NOT FOLLOWED AS THE HUMIDIFIER SHOULD NOT BE TURNED ON WHEN THERE IS NO GAS FLOW. NO AIR FLOW THROUGH THE CHAMBER RESULTS IN EXCESSIVE HEAT INSIDE THE CHAMBER WHICH MAY CAUSE THE PORTS TO DEFORM. THE WEIGHT OF THE IMPEDANCE VALVE WILL ALSO HAVE CONTRIBUTED TO THE DEFORMATION OF THE PORT. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. IN ADDITION, A VISUAL INSPECTION IS PERFORMED AFTER THE PORT CAPS ARE ASSEMBLED ON TO THE CHAMBER ON THE PRODUCTION LINE. ANY PRODUCT WHICH FAILS THIS VISUAL INSPECTION IS REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR850 HUMIDIFIER STATE: - IF GAS FLOW IS INTERRUPTED TURN THE HUMIDIFIER OFF.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE PORT OF AN MR290 HUMIDIFICATION CHAMBER HAD DEFORMED AFTER THREE DAYS OF USE. THE MR290V CHAMBER WAS SET UP WITH AN MR850 HUMIDIFIER AND A HUMMING V VENTILATOR. THE CUSTOMER HAS CONFIRMED THAT THE POWER TO THE FLOW SOURCE WAS TURNED OFF WHILST THE HUMIDIFIER WAS KEPT ON. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778252 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 140305

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL MR850 HUMIDIFIER| HUMMING V VENTILATOR