BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2992616 · Received February 11, 2013

    Report

    Report Number
    2992616
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HFNC (HIGH FLOW NASAL CANNULA) THERAPY TO PEDIATRIC PT., PT'S. SPO2 DECREASED DESPITE AN INCREASE IN FIO2, SUCTIONING AND ALBUTEROL TX. AFTER TROUBLESHOOTING, IT WAS NOTED THAT THE PRESSURE RELIEF/SAFETY VALVE HAD POPPED OPEN CAUSING THIS EFFECT TO THE PT. THE PT. HAD BEEN ON 8 LPM (LITERS PER MINUTE) OF OXYGEN WHEN THIS OCCURRED. THIS HAS BEEN REPORTED TO HAVE HAPPENED A TOTAL OF 3 TIMES SINCE CHANGING TO THIS PRODUCT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HIGH FLOW OXYGEN THERAPYDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59235 * OXYGEN BREATHING CIRCUIT, INFANT BTT FISHER & PAYKEL HEALTHCARE LTD RT 329 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 * NO OTHER THERAPIES| NO.