BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1997069 · Received February 21, 2011

    Report

    Report Number
    9611451-2011-00086
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). (B)(6). METHOD: THE RETURNED MR290 CHAMBER FEEDSET TUBING WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE FEEDSET TUBING REVEALED THAT INSUFFICIENT GLUE HAD BEEN APPLIED AT THE CONNECTION BETWEEN THE FEEDSET SPIKE AND THE TUBE, CAUSING IT TO SEPARATE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100301. 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. 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 FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290 AUTOFILL HUMIDIFICATION CHAMBER WAS LEAKING AT THE CONNECTION BETWEEN THE WATER BAG SPIKE AND THE WATER FEED TUBE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100301

    Patients

    Seq Age Sex Outcome Treatment
    1