BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HRCHAMBER

    MDR report key: 16269308 · Received January 30, 2023

    Report

    Report Number
    2020676-2023-00002
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    January 25, 2023
    Report Date
    January 30, 2023
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    PMA / PMN Number
    K100268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SOLEY FOR THE REPORTED ISSUE THAT A PATIENT EXPERIENCED A BAROTRAUMA DURING TREATMENT. UPON INSPECTION OF CHAMBER, SECHRIST TRAINED TECHNICIAN COULD NOT REPLICATE THE REPORTED FAILURE. THE CHAMBER TESTING REVEALED THAT THE CHAMBER IS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) 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 ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    DURING TREATMENT, CUSTOMER FOUND THAT THE CHAMBER WAS RUNNING TOO FAST. CAUSED BAROTRAUMA TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790189 SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HRCHAMBER CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES, INC. 4100H/HR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other