BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 25088619 · Received May 5, 2026

    Report

    Report Number
    2020676-2026-00006
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    UDI-DI
    00899660002123
    PMA / PMN Number
    K140559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT ON A FEW OCCASIONS THAT THE CHAMBER PRESSURE WAS PULSING/WHOOSHING UPON COMPRESSION ABOUT 2.4 ATA, WITH PATIENT COMPLAINTS OF EAR PAIN DURING TREATMENT. THE CHAMBER HAS BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN AND IT WAS VERIFIED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED. THE REPORTED ISSUE COULD NOT BE REPLICATED OR CONFIRMED. NO ISSUES WERE DISCOVERED THAT WOULD CONFIRM THAT THE CHAMBER WAS THE CAUSE OF THE PATIENTS EXPERIENCING BAROTRAUMA. BAROTRAUMA IS A MINOR INCONVENIENCE TO PATIENT THAT WILL RESOLVE ON ITS OWN OR WITH MINIMAL MEDICAL INTERVENTION. THIS REPORT IS BEING SUBMITTED SOLEY IN RESPONE TO A PATIENT INJURY BEING REPORTED AS THERE WAS NO ISSUES DISCOVERED UPON MANUFACTURER EVALUATION OF THE SUSPECTED DEVICE. 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 NOTED ON A FEW OCCASIONS THE CHAMBER PRESSURE PULSING/WHOOSHING UPON COMPRESSION AT 2.4 ATA, WITH PATIENT COMPLAINTS OF EAR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515272 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES INC. 3600HR-00-1 00899660002123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other