BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2180503 · Received July 27, 2011

    Report

    Report Number
    9611451-2011-00449
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 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: FIVE COMPLAINT CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AND VISUALLY INSPECTED. RESULTS: IN THREE OF THE CHAMBERS IT WAS OBSERVED THAT THE WATERBAG SPIKE HAD SEPARATED FROM THE TUBE. THE REMAINING TWO CHAMBER FEEDSETS WERE INTACT, SO THESE WERE CONNECTED TO A WATERBAG, BOTH CHAMBER FILLED UNTIL THE WATER FLOW WAS STOPPED BY THE FLOAT. NO LEAKS WERE FOUND EVEN THOUGH THE WATER FEEDSETS OF BOTH CHAMBERS WERE MANIPULATED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: THE LEAK IN THE THREE DEFECTIVE CHAMBERS WAS CAUSED BY THE APPLIED GLUE NOT BEING ABLE TO HOLD THE SPIKE TO THE FEEDSET TUBE. ALL THREE CHAMBERS APPEARED TO HAVE SUFFICIENT GLUE AND WE WERE UNABLE TO DETERMINE WHY THE GLUE BOND HAD FAILED. 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 LEAKS 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 WATER LEAKED AT THE CONNECTION BETWEEN THE FEED TUBE AND THE BAG SPIKE OF SEVERAL MR290 AUTOFEED HUMIDIFICATION CHAMBERS DURING USE. 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 110119

    Patients

    Seq Age Sex Outcome Treatment
    1