BEUDAMED
    FDA Adverse Event Other Summary report: N

    INGAGE REGULATOR

    MDR report key: 464910 · Received June 2, 2003

    Report

    Report Number
    1832475-2003-00001
    Event Type
    Other
    Date Received
    June 2, 2003
    Date of Event
    May 13, 2003
    Report Date
    May 13, 2003
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    REGULATOR PRESSIVE GAUGE INDICATED THAT CYLINDER TANK HAD USABLE QUANTITY OF OXYGEN. WHEN IN FACT GAUGE WAS NOT RESET TO ZERO PRIOR THAT ATTACHED TO CYLINDER AND VENT. REGULATOR DID NOT FLOW OXYGEN BECAUSE CYLINDER WAS EMPTY. SALES REP MADE CALL AND RETRAINED AND INSERVICED USERS ON PROPER USE. REGULATOR WAS RESET AND PUT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGAGE REGULATOR OXYGEN REGULATOR CAN FLOTEC, INC. DR820-600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other