BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2213757 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00500
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    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

    (B)(4). METHOD: THE RETURNED COMPLAINT MR290V CHAMBER WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO BE TESTED FOR FLOAT OPERATION AND OVERFILLING. RESULTS: NO VISIBLE DAMAGE WAS REVEALED DURING THE VISUAL INSPECTION. THE FLOATS FUNCTIONED CORRECTLY AND CONTROLLED THE ENTRY OF WATER INTO THE CHAMBER. THE CHAMBER FILLED SUCCESSFULLY, AND STOPPED FILLING AT 4MM BELOW THE MAXIMUM LINE. NO OVERFILLING OF THE CHAMBER OCCURRED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 110406. CONCLUSION: THE MR290 IS A SINGLE USE AUTOFEED HUMIDIFICATION CHAMBER THAT IS USED TO MAINTAIN A CONSTANT HUMIDITY LEVEL FOR THE PATIENT. IT HAS A UNIQUE DUAL FLOAT MECHANISM THAT USES INDEPENDENT FLOATS TO CONTROL THE AMOUNT OF WATER WHICH FLOWS INTO THE CHAMBER AND TO SAFELY MAINTAIN A CONSTANT WATER LEVEL INSIDE THE CHAMBER FOR OPTIMAL HUMIDIFICATION. UNDER NORMAL CIRCUMSTANCES, THE BLUE "PRIMARY" FLOAT CONTROLS THE WATER LEVEL IN THE CHAMBER AND THE WHITE "SECONDARY" FLOAT ACTS AS A BACKUP TO PREVENT OVERFILLING IF THE PRIMARY FLOAT FAILS TO OPERATE. WE WERE UNABLE TO REPLICATE THE REPORTED FAULT AS THE INVESTIGATION CONFIRMED THAT BOTH FLOATS WERE FUNCTIONING CORRECTLY AND NO FAULT WAS FOUND ON THE CHAMBER. FOLLOWING PRODUCTION, THE FLOAT MECHANISM OF EVERY MR290 CHAMBER IS PERFORMANCE TESTED 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 THAT WATER OVERFLOWED FROM AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WHEN CONNECTED TO A WATER BAG. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110406

    Patients

    Seq Age Sex Outcome Treatment
    1