BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 23098678 · Received September 19, 2025

    Report

    Report Number
    2020676-2025-00022
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 18, 2025
    Manufacturer
    SECHRIST INDUSTRIES
    Product Code
    CBF
    UDI-DI
    00899660002062
    PMA / PMN Number
    K140559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION OF THE SAFETY BLOCK, TECH OBSERVED THE SAFETY PIN WOULD NOT FULLY RETRACT DURING USE, AND ALSO OBSERVED THE CHAMBER PRESSURE INDICATOR WOULD NOT ACTIVATE WHILE PRESSURIZED. REBUILT THE SAFETY INTERLOCK AND CHAMBER PRESSURE INDICATOR AND VERIFIED FULL FUNCTION. DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING AND FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE RISK IS MITIGATED TO THE LOWEST REASONABLE LEVEL THROUGH LABELING AND/OR INSTRUCTIONS IN THE USER'S MANUAL. SECHRIST RECOMMENDS COMPLETING DAILY, WEEKLY AND SEMI-ANNUAL PERFORMANCE VERIFICATION ON THE CHAMBER TO DETECT ANY ISSUES AND PRECLUDE THE DEVICE FROM USE. IN INSTANCES WHERE THE CHAMBER IS FOUND TO FUNCTION OUTSIDE OF SPECIFICATION, SECHRIST SHOULD BE IMMEDIATELY NOTIFIED FOR TECHNICAL ASSISTANCE. 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 FILE NO.: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE RED CHAMBER PRESSURE INDICTOR IS NOT WORKING AND THAT ALSO THE DOOR LATCH IS GETTING STUCK AND NOT ALLOWING THE DOOR TO BE OPENED. ISSUE WAS DISCOVERED DURING CLINICAL CHECK AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398063 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES 3300HR-00-1 00899660002062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown