BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2213544 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00487
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 20, 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 CHAMBER WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BOTTLE TO TEST FOR LEAKS. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE WATERBAG SPIKE HAD SEPARATED FROM THE TUBE OF THE COMPLAINT CHAMBER. THE CHAMBER FILLED TO THE EXPECTED FILL LEVEL AND THEN SMALL DROPS OF WATER BEGAN TO LEAK FROM THE CONNECTION BETWEEN THE TUBE AND THE WATER BOTTLE SPIKE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE COMPLAINT CHAMBER APPEARED TO HAVE SUFFICIENT GLUE AND WE ARE UNABLE TO DETERMINE WHY THE GLUE BOND HAD FAILED ON ONE SIDE OF THE SPIKE. 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE WATER FEEDSET TUBE AND SPIKE OF THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING USE. 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 LTD MR290V 110126

    Patients

    Seq Age Sex Outcome Treatment
    1