BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1083135 · Received July 24, 2008

    Report

    Report Number
    9611451-2008-00449
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED TO THE MFR IN ANOTHER COUNTRY, FOR FURTHER INVESTIGATION. MORE INFO WILL BE PROVIDED ONCE EVALUATION IS COMPLETE. A LOT CHECK REVEALED THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE FOR THE GIVEN LOT NUMBER. THE CRACKS ARE LIKELY TO HAVE OCCURRED DURING USE FROM STRESSES INDUCED BY HIGH FREQUENCY OSCILLATIONS ON THE PLASTIC CHAMBER DOME FROM THE ADULT OSCILLATORY VENTILATOR. OUR MONITORING AND TRENDING OF THIS TYPE OF EVENT FOR CRACKING CHAMBERS SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0011%.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MR290HFV AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND TO LEAK WHILE IN SERVICE ON A PT. WATER WAS FOUND ON THE FLOOR IN FRONT OF THE 3100B VENTILATOR. NO PT CONSEQUENCE WAS REPORTED. ON CLOSER INSPECTION BY A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE, A HORIZONTAL CRACK WAS DISCOVERED IN THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV 071214

    Patients

    Seq Age Sex Outcome Treatment
    1 SENSORMEDIC| 3100B VENTILATOR