BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 1897134 · Received November 11, 2010

    Report

    Report Number
    9611451-2010-00688
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 1, 2010
    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 TWO RETURNED COMPLAINT DEVICES WERE VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION FOUND THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET SPIKE AND TUBE OF THE DEVICE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE 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." 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 THERE WAS A LEAK BETWEEN THE FEEDSET AND CHAMBER OF TWO MR290 VENTED AUTOFEED CHAMBER DURING SET UP. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 100220

    Patients

    Seq Age Sex Outcome Treatment
    1