BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2250421 · Received September 15, 2011

    Report

    Report Number
    9611451-2011-00576
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). DEVICE MANUFACTURE DATE: 110124 - 01/24/2011; 101216 - 12/16/2010. TWO COMPLAINT MR290V CHAMBERS, WITH LOT NUMBERS 110124 AND 101216, WERE RETURNED TO FPH (B)(4) FOR INSPECTION. BOTH CHAMBERS WERE VISUALLY INSPECTED AND PERFORMANCE TESTED. NO PHYSICAL DAMAGE WAS OBSERVED WITH THE RETURNED CHAMBERS. WHEN CONNECTED TO A WATER BOTTLE, BOTH CHAMBERS FILLED NORMALLY AND STOPPED FILLING BELOW THE MAXIMUM WATER LEVEL LINE. THE CHAMBER WITH LOT NUMBER 110124 FILLED SUCCESSFULLY TO ABOUT 7 MM ABOVE THE BASE WHILE THE ONE WITH LOT NUMBER 101216 ABOUT 5 MM. WE WERE UNABLE TO REPLICATE THE REPORTED FAULT AS OBSERVED BY THE HOSPITAL STAFF. NO FAULT WAS FOUND WITH THE RETURNED CHAMBERS AS BOTH FUNCTIONED NORMALLY DURING TESTING. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER STATE: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER WAS NOT FILLING FROM THE WATER BAG TO AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1