BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE® G3 OXYGEN CONCENTRATOR

    MDR report key: 19719749 · Received July 11, 2024

    Report

    Report Number
    3004672275-2024-00044
    Event Type
    Death
    Date Received
    July 11, 2024
    Date of Event
    January 23, 2024
    Report Date
    July 3, 2024
    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
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INOGEN HAS INITIATED AN INVESTIGATION TO ASSESS THE CAUSE OF THE DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ON JANUARY 3RD, 2024 INOGEN CONTACTED THE NUMBER ON FILE REGARDING THE RETURN OF THE DEVICE IN QUESTION. THE CONTACT ASSOCIATED WITH THE PHONE NUMBER ADVISED THAT THE PATIENT HAD PASSED AWAY AND THEY BELIEVE THAT THE INOGEN POC CONTRIBUTED TO THE PASSING OF THE PATIENT. THEY HAVE ALSO ADVISED THAT THE DEVICE WAS PICKED UP ON 12/25/23 AND WILL TRY TO PROVIDE THE TRACKING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271682 INOGEN ONE® G3 OXYGEN CONCENTRATOR INOGEN ONE® G3 OXYGEN CONCENTRATOR CAW INOGEN, INC IO-300 00817131020063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown