BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM VENTILATOR

    MDR report key: 4616900 · Received March 18, 2015

    Report

    Report Number
    2020676-2015-00016
    Event Type
    Death
    Date Received
    March 18, 2015
    Date of Event
    January 31, 2015
    Report Date
    March 1, 2015
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS NOT MADE AVAILABLE FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND RETURN OF THE REPORTED DEVICE. THE DISTRIBUTOR REPORTED MULTIPLE VISITS WITH THE USER FACILITY AND TESTING OF THE REPORTED DEVICE. THE UNIT FUNCTIONED AS DESIGNED. EDUCATION WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THERE IS NO SERVICE HISTORY ON FILE WITH THE MANUFACTURER FOR THE REPORTED DEVICE. A REVIEW OF THE COMPLAINT HISTORY INDICATES THERE IS NO SIGNIFICANT TREND. TRENDING WILL CONTINUE TO BE MONITORED. A REVIEW OF THE WARNING LABEL IN THE USER'S MANUAL STATES: "IF THE SECHRIST MILLENNIUM FAILS TO PERFORM AS DESCRIBED, REMOVE THE UNIT FROM SERVICE AND REFER IT TO A SECHRIST AUTHORIZED SERVICE TECHNICIAN. THE UNIT SHOULD NOT BE UTILIZED UNTIL PROPER PERFORMANCE HAS BEEN VERIFIED." AND "THE PERFORMANCE VERIFICATION SHOULD BE PERFORMED BY QUALIFIED TECHNICAL PERSONNEL AND SHOULD BE CONDUCTED PRIOR TO EACH CLINICAL APPLICATION OR AT LEAST ONCE PER MONTH, WHICHEVER IS SOONEST." SHOULD THE PRODUCT BE RETURNED OR NEW INFORMATION IS MADE AVAILABLE, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE TREATING THE NEONATE FOR SEVERE RESPIRATORY DISTRESS (CONGENITAL PNEUMONIA), THERE WAS A DISCREPANCY BETWEEN THE UNIT'S PEEP SETTING AND THE ACTUAL OUTPUT VALUES. THE STAFF RECOGNIZED THE DISCREPANCY AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS REPORTED THAT THE PATIENT EXPIRED THE NEXT DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE TREATING THE NEONATE FOR SEVERE RESPIRATORY DISTRESS (CONGENITAL PNEUMONIA), THERE WAS A DISCREPANCY BETWEEN THE UNIT'S PEEP SETTING AND THE ACTUAL OUTPUT VALUES. THE STAFF RECOGNIZED THE DISCREPANCY AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS REPORTED THAT THE PATIENT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185238 MILLENNIUM VENTILATOR INFANT VENTILATOR CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death| R IV FLUIDS