BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 21758643 · Received April 2, 2025

    Report

    Report Number
    2020676-2025-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 1, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    UDI-DI
    00852682007774
    PMA / PMN Number
    K100268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DURING WEEKLY TESTING THE LOCKING PIN DID NOT ENGAGE. NO PATIENT INVOLVEMENT. NO USER INJURY REPORTED. THE CHAMBER HAS NOT BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN YET SO SUBMISSION IS BASED ONLY ON THE USER REPORTED ISSUE. ONCE EVALUATION OF CHAMBER HAS BEEN COMPLETED AND THE ROOT CAUSE DETERMINED, THE REPORTED ISSUE WILL BE REVIEWED TO DETERMINE CONFIRMATION STATUS (CONFIRMED/NOT CONFIRMED). AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 A FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY THE FACILITY, "DURING WEEKLY CHECK, THE LOCKING PIN DID NOT ENGAGE." NO PATIENT INVOLVEMENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846755 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES INC. 4100H/HR 00852682007774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown