BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 1576870 · Received January 11, 2010

    Report

    Report Number
    9611451-2010-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Report Date
    December 18, 2009
    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

    (B)(4). THE LOT NUMBER OF THE FOURTH HUMIDIFICATION CHAMBER WAS PROVIDED TO FISHER & PAYKEL HEALTHCARE. THE LOT NUMBERS OF THE OTHER THREE (3) CHAMBERS ARE NOT AVAILABLE AS THE PRODUCTS WERE DISCARDED BY THE HOSPITAL. THE LOT NUMBER OF THE FOURTH HUMIDIFICATION CHAMBER IS 090131. THIS PRODUCT WAS MANUFACTURED ON 01/31/2009. THE COMPLAINT MR290HFV HUMIDIFICATION CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FOUR (4) MR290HFV HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER CRACKED NEAR THE CONNECTION POINT BETWEEN THE DOME AND THE BASE. IT WAS REPORTED THAT THE HOSPITAL NOTICED THE CRACKS AFTER THEY FOUND WATER "SPRAYING FROM THE CRACK" IN THE CHAMBERS. THE HOSPITAL DISPOSED OFF THE FIRST THREE (3) CHAMBERS AS THEY BELIEVED THE CRACKS WERE DUE TO PHYSICAL DAMAGE FROM HITTING THE CHAMBERS ON THE PATIENT'S BEDSIDE RAILING. THE FOURTH CHAMBER IS BEING RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290HFV

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY| HUMIDIFIER| VENTILATOR| VIASYS SENSORMEDICS 3100B HIGH FREQ. OSCILLATORY| FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT