BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25302630 · Received May 27, 2026

    Report

    Report Number
    3004672275-2026-00145
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 29, 2026
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE. AS THE DEVICE IS NOT RETURNED, NO OTHER INFORMATION IS AVAILABLE AT THIS TIME TO DETERMINE ANY OTHER PROBABLE CAUSE AND/OR THE EXACT CAUSE OF THE EVENT. IF THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LOSING THEIR DEVICE'S AC CORD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236847 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