BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC CHAMBER

    MDR report key: 6875912 · Received September 18, 2017

    Report

    Report Number
    MW5072201
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    October 1, 2011
    Report Date
    September 17, 2017
    Manufacturer
    VITAERIS / OXYHEALTH LLC
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WINDOW SEAM BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652222 HYPERBARIC CHAMBER CHAMBER, HYPERBARIC CBF VITAERIS / OXYHEALTH LLC 320

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR