BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G2 OXYGEN CONCENTRATOR

    MDR report key: 3853613 · Received May 23, 2014

    Report

    Report Number
    3004672275-2014-00002
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    July 8, 2013
    Report Date
    April 23, 2014
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BELOW EXCERPTS FROM THE DEVICE'S INFO FOR USE MANUAL ARE GIVEN IN THE CONTEXT OF THIS REPORT AND AS BACKGROUND. INTENDED USE: THE INOGEN ONE G2 OXYGEN CONCENTRATOR IS USED ON A PRESCRIPTIVE BASIS BY PATIENTS REQUIRING SUPPLEMENTAL OXYGEN. IT SUPPLIES A HIGH CONCENTRATION OF OXYGEN AND IS USED WITH A NASAL CANNULA TO CHANNEL OXYGEN AND IS USED WITH A NASAL CANNULA TO CHANNEL OXYGEN FROM THE CONCENTRATOR TO THE PATIENT. THE INOGEN ONE G2 MAY BE USED IN HOME, INSTITUTION, VEHICLE, ON AN AIRPLANE AND VARIOUS MOBILE ENVIRONMENTS. WARNING AVAILABILITY OF AN ALTERNATE SOURCE OF OXYGEN IS RECOMMENDED IN CASE OF POWER OUTAGE OR MECHANICAL FAILURE. CONSULT YOUR EQUIPMENT PROVIDER FOR TYPE OF BACK-UP SYSTEM RECOMMENDED. CONTRAINDICATIONS: WARNING THIS DEVICE IS NOT INTENDED TO BE LIFE SUSTAINING OR LIFE SUPPORTING.

    Description of Event or Problem · 1

    AS REPORTED TO INOGEN PER CLIENT SERVICES REPRESENTATIVE: THE HUSBAND OF THE DECEASED REPORTED THAT HIS WIFE'S DEATH WAS DUE TO HYPOXIA AS A CONSEQUENCE OF EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309107 INOGEN ONE G2 OXYGEN CONCENTRATOR PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-200

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death NONE AWARE OF BY MANUFACTURER.