BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAERIS 320 PACKAGE

    MDR report key: 7689303 · Received July 13, 2018

    Report

    Report Number
    MW5078391
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 11, 2018
    Manufacturer
    OXYHEALTH, LLC
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED AN OXYHEALTH VITAERIS 320. THE OXYGEN CONCENTRATOR PACKAGE THEY SOLD DIRECTLY TO ME STOPPED WORKING AND STARTED RUMBLING LOUDLY AND COULDN'T BREATHE WHILE IN THE UNIT, THE MASK WAS NOT SUPPLYING OXYGEN. I CALLED THEM TO COMPLAIN AND THEY CLAIMED THEY DON'T SELL IT, BUT I HAVE AN INVOICE OF THE PRODUCT AND SPENT THE MONEY, OXYHEALTH SAID THEY WOULD GIVE ME A DEAL AND CHARGE (B)(6). HOWEVER, WHEN I CALLED THEY SAID THEY DON'T SELL IT AND WON'T FIX THE CONCENTRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530410 VITAERIS 320 PACKAGE HYPERBARIC CHAMBER CBF OXYHEALTH, LLC V320

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other