BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G2 OXYGEN CONCENTRATOR

    MDR report key: 1767768 · Received July 21, 2010

    Report

    Report Number
    3004672275-2010-00002
    Event Type
    Death
    Date Received
    July 21, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 13, 2010
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INOGEN, INC. HAS REVIEWED THE DETAILS OF THIS EVENT. INOGEN DOES NOT BELIEVE THE INOGEN POC IS RESPONSIBLE FOR THE DEATH OF THIS PT. WITH THE MULTITUDE OF DEVICES IN USE WORLDWIDE, THIS SEEMS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PT WAS SUFFERING FROM MULTIPLE AILMENTS WHEN HE DIED, ONE OF WHICH MAY HAVE BEEN CARBON DIOXIDE POISONING, HIS DOCTORS NOTED. HE DID NOT SEEM TO BE EFFICIENTLY EXCHANGING GASES WHILE ON THE INOGEN POC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death