BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2115892 · Received June 7, 2011

    Report

    Report Number
    9611451-2011-00334
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT CHAMBERS WERE RETURNED, WITH LOT NUMBERS 100307 AND 101127 RESPECTIVELY. THE RETURNED COMPLAINT CHAMBERS WERE ATTACHED TO A WATERBAG FOR TESTING. RESULTS: ONE OF THE CHAMBERS FILLED TO THE EXPECTED FILL LEVEL AND THEN SMALL DROPS OF WATER BEGAN TO BUILD UP AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATER BAG SPIKE. WITH THE SECOND CHAMBER NO LEAKS WERE FOUND EVEN WHEN THE WATER FEEDSET WAS MANIPULATED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR EITHER LOT NUMBER. CONCLUSION: THE LEAK WAS CAUSED BY THE FEEDSET TUBING NOT BEING GLUED PROPERLY AT THE SPIKE, DUE TO INSUFFICIENT GLUE APPLIED BY THE GLUING MACHINE. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE LEAK DEVELOPED POST PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". AS PART OF OUR ONGOING PRODUCT IMPROVEMENTS, ADDITIONAL GLUE IS NOW APPLIED TO THE FEEDSET SPIKE DURING PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING AT THE WATER BAG SPIKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100307

    Patients

    Seq Age Sex Outcome Treatment
    1