BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC FLOPAC REGULATOR

    MDR report key: 5322447 · Received September 15, 2004

    Report

    Report Number
    1832475-2004-00003
    Event Type
    Malfunction
    Date Received
    September 15, 2004
    Date of Event
    August 11, 2004
    Report Date
    September 15, 2004
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: GAUGE SHOWED INACCURATE PRESSURE BECAUSE DECAL RING CAUGHT ON GAUGE BODY AS THE PRESSURE FELL. CAUSE: DECAL RING WAS ASSEMBLED WITHOUT REQUIRED DEBURR PROCESS BEING PERFORMED AND GAUGE TUBE WAS ASSEMBLED WITHOUT THE REQUIRED PRESET PROCESS BEING PERFORMED BY ASSEMBLY PERSONNEL AT FLOTEC. CORRECTIVE ACTION TAKEN: CAR-04-084, CREATE WORK INSTRUCTION FOR INGAGE SUB ASSEMBLY AND FUNCTION TEST PROCEDURE, AND TRAIN ASSEMBLY PERSONNEL ON NEW WORK INSTRUCTIONS (WI-PRO-052). CAR-04-086, RETAIN TEST STATION OPERATORS TO ENSURE TEST WORK INSTRUCTIONS WI-QAL-00 AND WI-QAL-002 ARE BEING FOLLOWED PROPERLY. CAR-04-085, REVISE TEST FIXTURE TO HOLD FLOTEC REGULATOR IN "IN USE POSITION" WHICH WILL ENHANCE THE FINAL TESTING PROCESS OF THE INGAGE PRESSURE GAUGE.

    Description of Event or Problem · 1

    VERBALLY REPORTED TO FLOTEC AS: PT UNDERGOING STRESS TEST EXPERIENCED LOW SPO2 LEVELS WHEN OXYGEN CYLINDER RAN OUT OF OXYGEN. CONTACTS GAUGE ON REGULATOR SHOWED INACCURATE PRESSURE RESULTING IN CYLINDER TANK RUNNING OUT OF OXYGEN BEFORE COMPLETION OF TEST. THE TEST HAD TO BE POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTEC FLOPAC REGULATOR PRESURE REGULATOR INTEGRATED WITH CYLINDERS VALVES CAN FLOTEC, INC. FP4-XX-BO5-7005T2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other