BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW

    MDR report key: 1439407 · Received July 22, 2009

    Report

    Report Number
    1439407
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    July 21, 2009
    Report Date
    July 22, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN RESPIRATORY FAILURE ON 100% O2 VIA NASAL INTERFACE. PATIENT'S O2 SAT NOTED TO DROP INTO 70S. NOSE PIECE OF OPTIFLOW NOTED TO BE DISCONNECTED. PIECE RECONNECTED, THEN O2 SAT NOTED TO INCREASE TO 94% MANUFACTURER RESPONSE (AS PER REPORTER) FOR O2 ADMINISTRATION, NASAL INTERFACEREPRESENTATIVE VISITED FACILITY, MET WITH RESPIRATORY THERAPY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW NASAL INTERFACE CAT FISHER & PAYKEL HEALTHCARE LTD * 090509

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR