BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 20946259 · Received December 16, 2024

    Report

    Report Number
    2020676-2024-00023
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 16, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    PMA / PMN Number
    K950386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON THE SECHRIST TECHNICAN REPORTED ISSUE DISCOVERED DURING PM SERVICE. CHAMBER HAS NOT BEEN REPAIRED AT THIS TIME AS WAITING FOR FACILITY TO SCHEDULE SERVICE. THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME TO DETERMINE ROOT CAUSE. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS FOR THE SAFE AND EFFECTIVE USE OF THIS DEVICE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVETHE 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

    DURING PM SERVICE BY SI TECHNICIAN, IT WAS DISCOVERED THAT THE EMERGENCY VENT WAS FALLING OUT OF SPECIFICATION AND NEEDS TO BE REPAIRED TO BRING BACK INTO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328334 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES INC. 3200-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown