BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOGEN ONE

    MDR report key: 1522966 · Received November 4, 2009

    Report

    Report Number
    MW5013335
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 10, 2009
    Report Date
    October 27, 2009
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE INOGEN ONE PORTABLE CONCENTRATOR DID NOT GIVE ANY WARNING THAT IT WAS MALFUNCTIONING. BREATH LIGHT WAS TRIGGERED AND NO O2 WAS DELIVERED. NO WARNING LIGHT OR ERROR CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOGEN ONE PORTABLE O2 CONCENTRATOR CAW INOGEN INC. IO-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other