BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2040468 · Received April 6, 2011

    Report

    Report Number
    9611451-2011-00218
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V CHAMBERS WERE VISUALLY INSPECTED FOR DAMAGE AND WERE CONNECTED TO WATERBAGS FOR FUNCTIONAL TESTING. RESULTS: EACH CHAMBER FILLED NORMALLY WHEN CONNECTED TO A WATERBAG, HOWEVER, ONCE THE CHAMBER HAD FILLED, SMALL DROPS OF WATER WERE OBSERVED TO LEAK FROM THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATERBAG SPIKE. INSPECTION SHOWED THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET TUBE AND SPIKE, CAUSING THE LEAK. A LOT CHECK REVEALED 99 OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100213. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." THE WATERFEED TUBING IS ATTACHED TO THE SPIKE BY AN AUTOMATED GLUING PROCESS. AS PART OF OUR ONGOING IMPROVEMENT PROCESS, ADDITIONAL GLUE IS NOW APPLIED TO THE WATER FEEDSET SPIKE DURING THE AUTOMATED ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE WATER FEEDSET TUBES OF TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS. 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 100213

    Patients

    Seq Age Sex Outcome Treatment
    1