BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 10770094 · Received November 2, 2020

    Report

    Report Number
    10770094
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    July 26, 2020
    Report Date
    September 10, 2020
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE ARE CURRENTLY NO ALARMS THAT NOTIFY IF THE SWEEP GAS HAS BEEN TURNED UP TOO LONG AND NO AUTOMATION TO SET THE FLOW METER FOR A SWEEP. WITHOUT THESE INDICATORS OR FEATURES, THERE IS A RISK FOR PROLONGED SIGH OF THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237903 SECHRIST INDUSTRIES, INC. MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR SECHRIST INDUSTRIES, INC. 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1