BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAERIS 320 HYPERBARIC OXYGEN CHAMBER

    MDR report key: 24666182 · Received March 23, 2026

    Report

    Report Number
    MW5185604
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 20, 2026
    Manufacturer
    OXYHEALTH, LLC
    Product Code
    CBF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED IN REGARDING A HYPERBARIC OXYGEN CHAMBER THAT SHE DECIDED TO TRY OUT SOMEWHERE. FOR 3 MONTHS SHE COULD GET UNLIMITED 1.5HR SESSIONS DAILY. PATIENT FELT HEADACHES AND LETHARGIC EACH TIME AFTER GETTING OUT OF THE CHAMBER. PATIENT CO2 LEVELS WERE 3,444 AFTER LEAVING THE CHAMBER. THE NEXT DAY THE PATIENT WENT AND MEASURED HER LEVELS AGAIN AND IT WAS 2,444. PATIENT REACHED OUT TO THE MANUFACTURER AND WAS OFFERED PART OF HER MONEY BACK. PATIENT HAS A CONCERN THAT THE CO2 LEVELS ISN'T BEING MONITORED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27027 VITAERIS 320 HYPERBARIC OXYGEN CHAMBER CHAMBER, HYPERBARIC CBF OXYHEALTH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female