BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 13916053 · Received March 26, 2022

    Report

    Report Number
    3015238204-2022-00043
    Event Type
    Death
    Date Received
    March 26, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 25, 2022
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    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

    INVESTIGATION REVEALED THAT THERE WAS NO DEVICE MALFUNCTION, AND THE CONCENTRATOR WAS FUNCTIONING AS INTENDED. INOGEN'S INVESTIGATION OF THE DEVICE IS COMPLETE. INOGEN IS STILL PENDING MEDICAL RECORDS FOR THE PATIENT AND WILL FILE A SUPPLEMENTAL REPORT, IF NECESSARY, WHEN INVESTIGATION THE INFORMATION IS RETRIEVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED LOW OXYGEN. IN TURN, THE PATIENT DIED (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977335 INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G4 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-400

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death