BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 20353022 · Received October 2, 2024

    Report

    Report Number
    3004672275-2024-00074
    Event Type
    Death
    Date Received
    October 2, 2024
    Date of Event
    June 24, 2024
    Report Date
    October 2, 2024
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020162
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTAMINATED COLUMN AND CRACKED SENSOR BLOCK CANNULA RECEPTACLE WERE THE CAUSE OF LOW EXTERNAL O2 22.8%. THE DIAGNOSTIC SCREEN SHOWED HIGH PRESSURE AND LOW SIEVE LIFE DUE TO CONTAMINATED COLUMN.

    Description of Event or Problem · 0

    THE PATIENT'S WIFE CALLED TO REPORT ISSUE WITH UNIT REGARDING IT NOT BEING ABLE TO HOLD A CHARGE FOR LONG AND IS PUTTING OUT LOW AMOUNT OF O2, WHICH RESULTS IN PT'S O2 LEVELS DROPPING. ACCORDING TO THE PATIENT'S WIFE, THEY WENT TO THE PATIENTS FOLLOW-UP APPOINTMENT WITH THE SURGEON AFTER HAVING SOME TOES AMPUTATED DUE TO DIABETES WHEN THE PATIENT BECAME SHORT OF BREATH. THE DOCTOR SAID THE POC WAS NOT WORKING, THE PATIENTS O2 LEVEL WAS 59% AND TO TAKE HIM TO THE HOSPITAL ACROSS THE STREET. THEY WENT TO ER, CALLED INOGEN, AND HE WAS ADMITTED DUE TO LOW OXYGEN. HE WAS ADMITTED FROM THE ER TO (B)(6) HOSPITAL ON (B)(6) 2024 WHERE THE PATIENT LATER DIED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351993 INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-500 00817131020162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H