BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAX FLUSH FLOW

    MDR report key: 3250741 · Received July 26, 2013

    Report

    Report Number
    3250741
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    July 26, 2013
    Manufacturer
    PRECISION MEDICAL INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS WAS ON 3L HFNC (HIGH FLOW NASAL CANNULA OXYGEN). STAFF NOTED FLOW WAS AT 1.5L AND CORRECTED BACK TO 3L. AGAIN FOUND LOWER THEN 3L (2L); FLOW SET BACK TO 3L. THE FOLLOWING DAY, FLOWMETER EXCHANGED AND SET AT FLOW OF 3L. FLOWMETER SENT TO BIOMED. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPTIFLOW HIGH FLOW HUMIDIFIED OXYGEN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350617 MAX FLUSH FLOW REGULATOR, PRESSURE, GAS CYLINDER CAN PRECISION MEDICAL INC. 8MFA *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY