BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMILLENNIUM INFANT VENTILATOR

    MDR report key: 3983291 · Received July 3, 2014

    Report

    Report Number
    2020676-2014-00024
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EMAIL WAS SENT TO THE DISTRIBUTOR TO ASSIST IN RESOLVING THE REPORTED FAILURE. THE CONTACT WAS INSTRUCTED TO CHECK THE PRESSURE DROP ACROSS THE AIR FILTERS. FURTHER INSTRUCTIONS STATED THAT BLOCKED FILTERS CANNOT BE CONFIRMED THROUGH VISUAL INSPECTION. THE DISTRIBUTOR REPORTED THAT "THE PROBLEM HAS BEEN SORTED OUT". ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE DISTRIBUTOR IN REGARD TO HOW THE ISSUE WAS RESOLVED. A FOLLOWUP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE FOLLOWING: THE VENTILATOR WAS SET UP WITH BOTH AIR AND OXYGEN PRESSURES SET AT 50 - 55 PSI. THERE ARE PRESSURE REGULATORS WITH FILTERS IN LINE (POST COMPRESSOR AND OXYGEN TANKS). THE FIO2 WAS AT 50% WITH THE FLOW SET AT 12 LITERS, PIP SET AT 22 (DELIVERING 8 - 9 CMH2O) AND PEEP SET AT 5 (DELIVERING 3 CMH2O). WHEN THE FIO2 WAS INCREASED TO 100%, THE PIP BECAME 18 - 19 CMH2O AND THE PEEP 4 CMH2O. TURNING DOWN THE FIO2 TO 21% CHANGED THE PRESSURE TO 4 -5 CMH2O. THE DISTRIBUTOR'S ENGINEER OPENED THE UNIT AND FOUND THE PRESSURE AT THE REGULATOR (POST MIXER) IS 18 CMH2O WHEN SET TO 100% FIO2 AND 0 CMH2O WHEN SET TO 21% FIO2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392304 LMILLENNIUM INFANT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1