BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1060012 · Received June 11, 2008

    Report

    Report Number
    9611451-2008-00238
    Event Type
    Malfunction
    Date Received
    June 11, 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

    THE RETURNED UNIT WAS TESTED TO SEE IF IT WOULD OVERFILL. RESULTS: THE CHAMBER FUNCTIONED CORRECTLY AND DID NOT OVERFILL WHEN CONNECTED TO A WATER BAG. A DENT WAS OBSERVED IN THE BASE OF THE DEVICE BELOW THE HINGE BRACKET ON THE AUTOFEED VALVE. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: THE DENT SUGGESTS THE DEVICE HAD SUFFERED AN IMPACT AND THIS COULD HAVE PREVENTED FLOAT OPERATION. WHEN THE DEVICE WAS EVALUATED, NO FAULT WAS FOUND IN THE FLOATS, SUGGESTING TRANSPORTATION VIBRATION MAY HAVE CAUSED THE FLOATS TO WORK AGAIN. THE MR290 INSTRUCTIONS FOR USE INDICATES THE CORRECT WATER LEVEL AND ADVISES THE USERS TO REPLACE THE CHAMBER SHOULD THE WATER EXCEED THE LIMIT LINE. WE HAVE AN OPEN CAPA ITEM TO ADDRESS SUCH COMPLAINTS AND HAVE PUT MEASURES IN PLACE TO REDUCE AND/OR PREVENT RECURRENCE. ONE MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.00129%.

    Description of Event or Problem · 1

    REPORTER REPORTED TO OUR DISTRIBUTOR THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER HAD OVER FILLED DURING USE, WHILE CONNECTED TO A VENTILATOR. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290 071008

    Patients

    Seq Age Sex Outcome Treatment
    1