BEUDAMED
    FDA Adverse Event Summary report: N

    DIAL FLOWMETER

    MDR report key: 2222469 · Received August 17, 2011

    Report

    Report Number
    2222469
    Date Received
    August 17, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 16, 2011
    Manufacturer
    PRECISION MEDICAL
    Product Code
    CAX
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLOWMETER DOES NOT PROVIDE OXYGEN WHEN BETWEEN THE NUMBERS OF THE DIAL. AT SOME POINT, THE BED WHEEL KINKED THE OXYGEN TUBING, CAUSING A HISSING SOUND. AN UNIDENTIFIED PERSON LIKELY CHANGED THE DIAL SETTING TO BETWEEN THE NUMBERS TO PREVENT NOISE, UNAWARE IT STOPPED OXYGEN FLOW. OTHER FLOWMETERS ALLOW FLOW BETWEEN THE SETTINGS IN A CONTINUOUS FLOW INCREASE, BUT THESE FLOWMETERS ONLY PROVIDE OXYGEN WHEN "CLICKED" INTO A SPECIFIC NUMBER, CAUSING CONFUSION AND NO OXYGEN TO THE PATIENT IF NOT SET CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAL FLOWMETER FLOWMETER CAX PRECISION MEDICAL 7MFA *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO OTHER THERAPIES