BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC FLOPAC REGULATOR

    MDR report key: 904452 · Received October 26, 2004

    Report

    Report Number
    1832475-2004-00004
    Event Type
    Malfunction
    Date Received
    October 26, 2004
    Date of Event
    July 27, 2004
    Report Date
    October 15, 2004
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GAUGE SHOWED AN INACCURATE PRESSURE AS PRESSURE IN CYLINDER TANK WAS REDUCED. CAUSE: DECAL RING WAS ASSEMBLED WITHOUT ADEQUATE DEBURN AND REQUIRED PRESET PROCESS DURING ASSEMBLY. PREVIOUSLY ISSUED CORRECTIVE ACTIONS HAS PREVENTED EVENTS SINCE THEY WERE PUT INTO PLACE. ADD'L STEPS: ECN ON USER INSTRUCTIONS AND TRANSFILLER INSTRUCTION CLARIFYING AND MODIFYING CHECKS ON FUNCTION OF GAUGE TO CHECK FOR DAMAGE AND/OR FUNCTION AND CALIBRATION.

    Description of Event or Problem · 1

    DURING A PULM. REHAB SESSION PT ON STRESS TEST EXPERIENCED LOW SPO2 LEVELS WHEN OXYGEN CYLINDER RAN OUT OF OXYGEN. CONTENTS GAUGE SHOWED INACCURATE PRESSURE RESULTING IN CYLINDER TANK RUNNING OT OF OXYGEN BEFORE COMPLETION OF TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC FLOPAC REGULATOR PRESSURE REGULATOR INTIGRATED WITH CYLINDER VALVE CAN FLOTEC, INC. FP4-XX-B05-7005T2 M625000

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other