BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 20306770 · Received September 25, 2024

    Report

    Report Number
    2020676-2024-00016
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    PMA / PMN Number
    K052713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DURING TREATMENT IN A SECHRIST MONOPLACE HYPERBARIC CHAMBER THAT THE PATIENT HAD A SEIZURE. THE CUSTOMER WANTED THE CHAMBER EVALUATED TO SEE IF FUNCTIONING AS INTENDED OR NOT. AFTER THE CHAMBER WAS EVALUATED BY TRAINED SECHRIST TECHNICAIN, IT WAS DETERMINED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. THERERFORE, 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 TO SECHRIST THAT DURING TREATMENT IN SECHRIST MONPLACE HYPERBARIC CHAMBER, THE PATIENT EXPERIENCED A SEIZURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291885 SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER, STATIONARY CBF SECHRIST INDUSTRIES, INC. 3300ER-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other