BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM VENTILATOR

    MDR report key: 5817731 · Received July 22, 2016

    Report

    Report Number
    2020676-2016-00009
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 22, 2016
    Report Date
    June 22, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INSPECTED PER DOCUMENTS 150009 REV. 40, 170025 REV. 36, 170310 REV. 14 AND, 150127 REV. 13. THE UNIT WAS CHECKED TO VERIFY THE CUSTOMER COMPLAINT, MAXIMUM INSPIRATORY PRESSURE IS LOWER THAN SPECIFICATION, MAXIMUM EXPIRATORY PRESSURE IS HIGHER THAN SPEC., AND MINIMUM EXPIRATORY PRESSURE IS HIGHER THAN SPECIFICATION. AFTER THE INITIAL VERIFICATION WAS DONE THE EXHALATION VALVE WAS INSPECTED AND A BIT OF CARDBOARD WAS FOUND ON THE DIAPHRAGM. THE DEBRIS WAS REMOVED FROM THE DIAPHRAGM AND INSPIRATORY PRESSURE DID FALL WITHIN SPECIFICATION. THE MAXIMUM INSPIRATORY PRESSURE BEING OUT OF SPECIFICATION IS DUE TO THE DEBRIS ON THE EXHALATION DIAPHRAGM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CLINICAL CHECK THE VENTILATOR PRESSURE WOULD NOT EXCEED 63 CMH20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469007 MILLENNIUM VENTILATOR INFANT VENTILATOR CBK SECHRIST INDUSTRIES, INC. 20409-1

    Patients

    Seq Age Sex Outcome Treatment
    1