BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 3465911 · Received November 5, 2013

    Report

    Report Number
    2020676-2013-00026
    Event Type
    Death
    Date Received
    November 5, 2013
    Date of Event
    September 10, 2013
    Report Date
    November 5, 2013
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INFO PROVIDED, THE VENTILATOR HAS NOT BEEN OVERHAULED. THE MFR RECOMMENDS THAT THE VENTILATOR BE OVERHAULED EVERY 2 YEARS. THE DEVICE IS 4 YEARS OLD. THE MFR HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE EVENT, THE PT AND THE PT'S DEATH. A RESPONSE HAS NOT BEEN RECEIVED. ADDITIONAL F/U ATTEMPTS WILL CONTINUE. A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE MFR RECEIVED AN EMAIL STATING THAT THE VENTILATOR PRESSURE WILL NOT RISE ABOVE 20CMH20. AN INCIDENT QUESTIONNAIRE WAS SENT TO THE DISTRIBUTOR TO OBTAIN ADDITIONAL INFO. ON (B)(6) 2013, THE MFR RECEIVED THE INCIDENT QUESTIONNAIRE BACK FROM THE DISTRIBUTOR. THE FOLLOWING DOCUMENTATION WAS PROVIDED: THE EVENT OCCURRED DURING CLINICAL USE. AFTER 10-12 HOURS OF USE THE VENTILATOR STARTED ALARMING ALERTING THAT THERE WAS A PEEP RISE AND INSPIRATORY PRESSURE ISSUE WITH THE DEVICE. THE PT WAS REMOVED FROM THE DEVICE AND PLACED ON A DIFFERENT VENTILATOR. AT SOME UNK POINT IN TIME THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568931 MILLENNIUM INFANT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death