BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMBER AUTOFEED VENTED

    MDR report key: 1071370 · Received July 8, 2008

    Report

    Report Number
    9611451-2008-00424
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE RETURNED COMPLAINT DEVICE WAS MECHANICALLY INSPECTED FOR OVERFILLING. RESULTS - THE COMPLAINT DEVICE WAS FOUND TO HAVE A LARGE BOW IN THE ALUMINUM BASE TO THE RIGHT OF THE HINGE BRACKET. WHEN CONNECTED TO A WATER BAG, THE PRIMARY FLOAT OF THE HUMIDIFICATION CHAMBER OPENED CORRECTLY, STOPPING AT THE WATER LEVEL JUST BELOW THE MAXIMUM FILL LINE. OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSION: THE REPORTED FAULT CANNOT BE CONFIRMED AS THE COMPLAINT DEVICE WAS FUNCTIONING CORRECTLY AND DID NOT OVERFILL. THE DAMAGE TO THE BASE SHOWED THAT THE HUMIDIFICATION CHAMBER HAD BEEN DROPPED BY THE CUSTOMER. OUR MONITORING AND TRENDING FOR OVERFILLING OF HUMIDIFICATION CHAMBER HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.001%.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY REPORTED THROUGH OUR DISTRIBUTOR THAT WHILE AN AUTOFEED VENTED HUMIDIFICATION CHAMBER WAS BEING USED, THE WATER TRAP BECAME FULL AND THE DISTILLED WATER INSIDE MOVED UP TO THE UPPER CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAMBER AUTOFEED VENTED BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290EJ 071008

    Patients

    Seq Age Sex Outcome Treatment
    1