BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE OXYGEN CONCENTRATOR

    MDR report key: 2573495 · Received April 2, 2012

    Report

    Report Number
    3004672275-2011-00002
    Event Type
    Death
    Date Received
    April 2, 2012
    Date of Event
    February 26, 2011
    Report Date
    October 3, 2011
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT'S FAMILY COMPLAINED OF SUSPECTED DEVICE MALFUNCTION RESULTING IN HOSPITALIZATION AND SUBSEQUENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOGEN ONE OXYGEN CONCENTRATOR PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death