BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 23353011 · Received October 21, 2025

    Report

    Report Number
    2020676-2025-00026
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 9, 2025
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    UDI-DI
    00852682007927
    PMA / PMN Number
    K950386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE HAS NOT BEEN EVALUATED BY SECHRIST AT THIS TIME EVENTHOUGH WE HAVE REAHCED OUT TO USER TO SCHEDULE SERVICE CALL. THIS REPORT IS BASED ONLY ON THE INFORMATION PROVIDED BY USER WHEN REPORTING ISSUE TO SECHRIST. ONCE DEVICE IS EVALUATED AND ROOT CAUSE DETERMINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEEDED. 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).

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE WAS EVALUATED BY SECHRIST. THE RESTRICTOR THAT CONTROLS THE EMERGENCY DECOMPRESSION WAS REPLACED AND THE EMERGENCY DECOMPRESSION WAS CONFIRMED TO BE IN SPECIFICATION. THE RESTRICTOR'S FAILURE IS DUE TO NORMAL WEAR AND TEAR. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING PRE-CLINICAL CHECK THE CHAMBER IS FALLING OUTSIDE THE 120 SECOND TIME FRAME TO BE IN SPEC FOR THE EMERGENCY VENTING. NO PATIENT INVOLVEMENT OR PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531815 SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES, INC. 3200R 00852682007927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown