BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERBARIC CHAMBER

    MDR report key: 6669642 · Received June 24, 2017

    Report

    Report Number
    MW5070651
    Event Type
    Injury
    Date Received
    June 24, 2017
    Date of Event
    June 18, 2017
    Report Date
    June 24, 2017
    Manufacturer
    OXYHEALTH, LLC
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A VITAERIS 320 FROM OXYHEALTH. I TURNED IT ON AND AFTER FULL PRESSURE THE BIG WINDOW EXPLODED IN THE CORNER AND ALL THE AIR CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446549 HYPERBARIC CHAMBER HYPERBARIC CHAMBER CBF OXYHEALTH, LLC VITAERIS 320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention