BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2791962 · Received October 16, 2012

    Report

    Report Number
    9611451-2012-00731
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    September 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: BOTH COMPLAINT MR290 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE CHAMBERS WERE CONNECTED TO A WATER BAG TO TEST FOR LEAKS. RESULTS: THE WATER FILLED BOTH CHAMBERS UNTIL THE WATER FLOW WAS STOPPED BY THE FLOAT. THEN SMALL DROPS OF WATER STARTED TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE OF BOTH CHAMBERS. A LOT CHECK REVEALED 15 OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 100213 CONCLUSION: THE CAUSE OF THE FAULT WAS DETERMINED TO BE INSUFFICIENT GLUE BEING APPLIED TO THE FEEDSET TUBING AT 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". 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 VIA A FPH FIELD REPRESENTATIVE THAT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE SPIKE OF TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WAS LEAKING. 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 100213

    Patients

    Seq Age Sex Outcome Treatment
    1