BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 22670049 · Received July 30, 2025

    Report

    Report Number
    2020676-2025-00019
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 30, 2025
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    DTX
    UDI-DI
    00899660002345
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED LIMITED INFORMATION ABOUT GAS OUTPUT ISSUE INTIALLY. WE HAVE REQUESTED MORE INFORMATION BUT HAVE NOT RECEVIED AS OF YET. THIS REPORT IS BASED SOLEY ON USER REPORTING DEVICE NOT DELIVERING SET OXYGEN CONCENTRATION. NO PATIENT INJURY REPORTED. DEVICE IN QUESTION HAS NOT BEEN EVALUATED BY SECHRIST AT THIS TIME. THE DEVICE IN QUESTION IS PAST ITS SERVICE LIFE AND CAN NO LONGER BE SERRVICED BY SECHRIST. CUSTOMER HAS BEEN INFORMED OF THIS. AT THIS TIME, THE REPORT IS BASED ON THE INFORMATION WE HAVE. WE HAVE REQUESTED MORE INFORMATION FROM CUSTOMER SO WE CAN COMPLETE INVESTIGATION. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS FOR THE SAFE AND EFFECTIVE USE OF THIS DEVICE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTING, "THE OXYGEN BLENDER WAS NOT PROVIDING 100% OXYGEN, AS IT WAS SET TO, BUT A MUCH LOWER FIO2." NO PATIENT INVOLVEMENT OR INJURY REPORTED. NO OTHER INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496565 SECHRIST INDUSTRIES, INC. AIR/OXYGEN GAS MIXER DTX SECHRIST INDUSTRIES, INC. 3500CP-G 00899660002345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown