BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 23414822 · Received October 29, 2025

    Report

    Report Number
    3004672275-2025-00155
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 29, 2025
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT IS ESTIMATED. THE UNIT WAS RETURNED FOR INVESTIGATION ON 16-OCT-2025. THE UNIT CAME IN FOR POWER PORT DAMAGED. THE COMPLAINT WAS CONFIRMED WITH THE BURNED J20 IN THE MOTHER BOARD & DAMAGED POWER INPUT. MOTHER BOARD BURNED DUE TO THE OVERCURRENT, LOW VOLTAGE EVENT. POWER INPUT DAMAGED DUE TO WEAR & TEAR ON GOLD PADS. BLOCKED FEED PORT CAUSED HIGH COLUMN PRESSURE. THE DATA LOG SHOWS NUMEROUS BATTERY LOW ERRORS. THIS MEANS THE PATIENT RUNNING THE UNIT ON LOW BATTERY. UNIT WORKS FINE WITH A GOOD BATTERY. SENSOR BLOCK LEAK DUE TO OVERTIGHTENING CANNULA BARB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UNIT HAD DAMAGE TO THE POWER PORT. ADDITIONALLY, THE UNIT STOPPED WORKING RESULTING IN THE PATIENT'S OXYGEN SATURATION LEVELS TO DROP. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. A REPLACEMENT UNIT WAS SENT TO THE PATIENT, HOWEVER ADDITIONAL ATTEMPTS TO FOLLOW-UP FOR MORE INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212408 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 Hospitalization