BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFICATION CHAMBER

    MDR report key: 1063641 · Received June 19, 2008

    Report

    Report Number
    9611451-2008-00377
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 30, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND A PHOTOGRAPH OF THE DEVICE PROVIDED TO THE MANUFACTURER. RESULTS: IN THE PHOTOGRAPH AN L SHAPED CRACK WAS OBSERVED ON THE SIDE OF THE CHAMBER, AWAY FROM KNOWN STRESS POINTS. CONCLUSION: BECAUSE OF THE SHAPE OF THE CRACK, AND ITS POSITION ON THE CHAMBER AWAY FROM KNOWN STRESS POINTS, IT IS LIKELY THAT THE CRACK OCCURRED AS A RESULT OF AN IMPACT. ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE CRACK OCCURRED POST PRODUCTION, DURING TRANSPORT, STORAGE OR USE. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RAGE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0014%.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN ANOTHER COUNTRY, REPORTED THAT A CRACK WAS FOUND IN AN MR210 HUMIDIFICATION CHAMBER DURING SETUP. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR210 071002

    Patients

    Seq Age Sex Outcome Treatment
    1