BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOTEC, INC

    MDR report key: 1469466 · Received August 27, 2009

    Report

    Report Number
    MW5012641
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    June 6, 2009
    Report Date
    August 27, 2009
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OXYGEN REGULATOR CONTENTS GAUGE READ FULL WHEN THE TANK WAS EMPTY CAUSING A POTENTIALLY LIFE THREATENING SITUATION IN HOME USE IN 2009. HOME CARE PT WAS STRESSED AND IN IMMEDIATE NEED OF O2. TANK WAS EMPTY, BUT GAUGE WAS STUCK TO SHOW FULL. HAD TO CALL EMS FOR OXYGEN. REGULATOR WAS PRINTED WITH FLOTEC, INC., AND "INGAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC, INC INGAGE OXYGEN REGULATOR CAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening