BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 20614469 · Received November 5, 2024

    Report

    Report Number
    2020676-2024-00020
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 5, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    UDI-DI
    00899660002147
    PMA / PMN Number
    K140559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER IS REPORTING THAT THE CHAMBER IS EXTREMELY SLOW TO DECOMPRESS AT THE END OF THE TREATMENT AND HOLDING BACK RESIDUAL PRESSURE WHEN THE DOOR IS OPENED. PATIENT MADE COMPLAINT OF EAR PAIN WHEN DOOR WAS OPENED BY STAFF. THE CHAMBER WAS EVALUATED BY A TRAINED SECHRIST TECHNICIAN, IT WAS DETERMINED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THEREFORE, THE PATIENT INCIDENT WAS NOT A RESULT OF THE CHAMBER NOT FUNCTIONING PROPERLY. 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 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 THIS FAILURE MODE WILL BE ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED, "THE CHAMBER IS EXTREMELY SLOW TO DECOMPRESS AT THE END OF TREATMENT AND HOLDING BACK RESIDUAL PRESSURE WHEN THE DOOR IS OPENED. PATIENT MADE COMPLAINT OF EAR PAIN WHEN THE DOOR WAS OPENED BY STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860339 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES INC. 3600HR-01-1 00899660002147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown