BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 23638158 · Received November 24, 2025

    Report

    Report Number
    2020676-2025-00028
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 24, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    DTX
    UDI-DI
    00899660002345
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS EVALUATED BY SECHRIST AND DETERMINED THAT THE REED WAS DEFECTIVE WHICH LED TO THE ALARM NOT SOUNDING PROPERLY. THE REED WAS REPLACED AND THE UNIT WAS TESTED AND FOUND TO BE ALARMING PROPERLY NOW. THE IFU STATES, PRIOR TO EACH CLINICAL USE, THE USER SHALL PERFORM BYPASS ALARM SYSTEM TEST, VERIFY ACCURACY OF O2 AND INSPECT THE REVERSE GAS FLOW. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. 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 NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE MIXER WON'T ALARM AND HAS A HISSING SOUND COMING FROM IT. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2660964 SECHRIST INDUSTRIES INC. AIR/OXYGEN GAS MIXER DTX SECHRIST INDUSTRIES INC. 3500CP-G 00899660002345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown