BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 23147504 · Received September 25, 2025

    Report

    Report Number
    2020676-2025-00023
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    PMA / PMN Number
    K140559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECHRIST INDUSTRIES TECHNICIAN TROUBLE SHOOTING OF ISSUE RESULTED IN REPLACING FLOW RESTRICTOR ORIFICE. AFTER REPLACING, THE EMERGENCY VENT TOGGLE SWITCH WAS TESTED AND VERIFIED TO BE EMERGENCY VENTING WITHIN SPECIFICATION. NORMAL WEAR AND TEAR OF COMPONENT ATTRIBUTTED TO THE REPORTED ISSUE AS THE CHAMBER IS OVER TWELVE (12) YEARS OLD. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED ISSUE, 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'S REFERENCE NO.: (B)(4).

    Description of Event or Problem · 0

    DURING REPAIR OF SECHRIST MONOPLACE HYPERBARIC CHAMBER BY SECHRIST INDUSTRIES TRAINED TECHICIAN, IT WAS DISCOVERED THAT THE EMERGENCY DECOMPRESSION WAS OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849761 SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES, INC. 3300H-01-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown