BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3526620 · Received December 18, 2013

    Report

    Report Number
    9611451-2013-01023
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 27, 2013
    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 MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED AND PERFORMANCE TESTED BY CONNECTING IT TO A WATER BAG. RESULTS: INSPECTION OF THE COMPLAINT CHAMBER REVEALED THAT THERE WAS NO DAMAGE TO THE CHAMBER AND THAT BOTH PRIMARY AND SECONDARY FLOATS WERE MOVING FREELY. WHEN CONNECTED TO THE WATER BAG THE CHAMBER OVERFILLED ABOUT 5MM ABOVE THE MAXIMUM FILL LINE. THE PRIMARY FLOAT FAILED TO STOP THE FLOW OF WATER. HOWEVER, THE SECONDARY FLOAT FUNCTIONED AS INTENDED AND STOPPED THE WATER LEVEL RISING ANY HIGHER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130604. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE FAULT. THE CHAMBER INCORPORATES A SECONDARY FLOAT THAT OPERATES TO PREVENT OVERFILLING OF THE CHAMBER IN THE EVENT OF A FAILURE OF THE PRIMARY FLOAT. THE SECONDARY FLOAT THUS FUNCTIONED AS INTENDED. ALL MR290 CHAMBERS HAVE THEIR FLOAT FUNCTIONS AND VALVES TESTED TWICE ON THE PRODUCTION LINE AND THOSE THAT FAIL THE TEST ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER INDICATE IN PICTORIAL FORM THE MAXIMUM FILL LINE AND ADVISE THE USER TO REPLACE THE CHAMBER SHOULD WATER EXCEED THE MAXIMUM FILL LINE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL FIELD REPRESENTATIVE THAT WATER OVERFLOW OCCURRED WHEN THEY STARTED TO FEED WATER TO AN MR290 HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662567 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1306040304

    Patients

    Seq Age Sex Outcome Treatment
    1