BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1111857 · Received August 13, 2008

    Report

    Report Number
    9611451-2008-00487
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    July 16, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED FOR CRACKS. RESULTS: A CRACK WAS OBSERVED RUNNING HORIZONTALLY ALONG THE CHAMBER WALL, NEAR WHERE THE RIM MEETS THE ALUMINUM BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS LIKELY THAT A SMALL CRACK OCCURRED DURING PRODUCTION WHICH WAS EXACERBATED AND LED TO A LEAK WHEN THE CHAMBER WAS UNDER PRESSURE. OUR MONITORING AND TRENDING OF CRACKS OF THIS NATURE IN MR290 CHAMBERS WORLDWIDE FOR THE LAST YEAR HAS A RATE OF OCCURRENCE OF 0.0001%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING DUE TO A CRACK NEAR THE BASE RIM. NO PT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290 080312

    Patients

    Seq Age Sex Outcome Treatment
    1