BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 14017743 · Received April 5, 2022

    Report

    Report Number
    3015238204-2022-00048
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 5, 2022
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020063
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED TO DETERMINE THE CAUSE OF THE MALFUNCTION. INOGEN'S INVESTIGATION OF THE DEVICE IS COMPLETE. THIS UNIT IS RUNNING NORMALLY AND AS DESIGNED. INOGEN WILL WRITE A SUPPLEMENTAL FILING WITH ANY ADDITIONAL INFORMATION GATHERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED LOW OXYGEN OUTPUT. REPORTEDLY, THE PATIENT OXYGEN UNIT LEVEL WAS TWO. IN TURN, THE PATIENT'S NIECE INCREASED THE PATIENT'S OXYGEN LEVELS, AND TRANSFERRED THE PATIENT TO THE HOSPITAL. WHILE THE PATIENT'S OXYGEN OUTPUT LEVELS WERE INCREASED, THE UNIT BEGAN GETTING HOT. AS A RESULT, THE PATIENT'S OXYGEN LEVELS INCREASED ONCE THE OXYGEN OUTPUT WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048907 INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization