BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 22021872 · Received May 14, 2025

    Report

    Report Number
    2020676-2025-00015
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 13, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    UDI-DI
    00899660002055
    PMA / PMN Number
    K140559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CONFIRMED NO ISSUES WITH CHAMBER SO NO NEED FOR SECHRIST TO EVALUATE CHAMBER AS INITIALLY REQUESTED. SECHRIST IS REPORTING BASED ONLY ON THE REPORTED PATIENT INJURY (SEVERE CRAMPING) EVEN THOUGH INJURY HAS BEEN CONFIRMED NOT TO BE A RESULT OF OUR CHAMBER. 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 TO SECHRIST THAT SEVERAL PATIENTS HAVE COMPLAINED OF SEVERE CRAMPING AFTER COMING OUT OF THE CHAMBER. CUSTOMER DID NOT REPORT ANY ISSUES WITH THE CHAMBER. THEY REQUESTED SECHRIST COME OUT AND EVALUATE THE CHAMBER ANYWAY. THEY WERE ALSO GOING TO CONTACT THE SUPPLIER OF THEIR MEDICAL GAS FOR A PURITY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882276 SECHRIST INDUSTRIES INC. MONOPLACE HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES INC. 3300HR-01-0 00899660002055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other