BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 3962700 · Received June 19, 2014

    Report

    Report Number
    2020676-2014-00023
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVAL. UPON RECEIPT, IT WAS NOTED THAT PLUG FITTING WAS MISSING FROM TH SIDE OF THE VENTILATOR. AN EVAL PLUG WAS USED, HOWEVER, THE EVALUATOR DID NOTE THAT THE THREADS THE PLUG SCREWS INTO WERE DAMAGED. EVAL OF THE VENTILATOR DID VERIFY THAT THERE WAS NO OUTPUT PRESSURE. THE DUMP VALVE WAS STUCK IN THE OPEN POSITION DIRECTLY CAUSING THE FAILURE. AS THE VENTILATOR TRIED TO BUILD PRESSURE THE PRESSURE WAS BEING RELEASED. FURTHER REVIEW OF THE DEVICE FOUND THE FOLLOWING: FOREIGN HARDWARE WAS INSTALLED IN THE VENTILATOR. THE MANUFACTURER USES STAINLESS STEEL SCREWS HOWEVER, CADMIUM PLATED SCREWS WERE FOUND. ONE OF THE TWO POPPETS WAS BEHIND THE ELECTRONIC SIDE OF THE BACK PANEL. THE POPPETS MUST BE IN FRONT OF THE PANEL TO FUNCTION. THE DIAPHRAGM AND EXHALATION BLOCK WERE NOT INSTALLED PROPERLY AT TIME OF ARRIVAL. TUBING FROM INSIDE THE VENTILATOR WAS PINCHED ON THE SENSE LINE UNDER THE BACK PLATE. THE ROOT CAUSE FOR THE DEVICE NOT FUNCTIONING PER SPECIFICATION WAS TAMPERING AND/OR ATTEMPTED MAINTENANCE. THERE IS NO SVC HISTORY FOR THIS DEVICE ON FILE WITH THE MANUFACTURER. VENTILATOR SN (B)(4) IS 6 YEARS PAST DUE FOR THE RECOMMENDED 2 YEAR OVERHAUL.

    Description of Event or Problem · 1

    DURING PRE-CLINICAL TESTING, THE VENTILATOR WAS NOT BUILDING PRESSURE. PER THE INFO PROVIDED, THERE WAS NO PT INVOLVEMENT AND THE DEVICE WAS REMOVED FROM SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359161 MILLENNIUM INFANT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1