BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25222377 · Received May 19, 2026

    Report

    Report Number
    3004672275-2026-28515
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 19, 2026
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020513
    PMA / PMN Number
    K230052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE BATTERY ERROR MESSAGE AND THE FAN WAS NOISIER WHILE THE PATIENT WAS AT WORK. IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVELS HAD DROPPED BELOW 75% AND EXPERIENCED DIFFICULTY BREATHING DUE TO THE EVENT. AS A RESULT, THE PATIENT WENT BACK HOME TO THEIR STATIONARY OXYGEN CONCENTRATOR AND THEY LATER REPLACED THEIR DEVICE. PATIENT HAS NO ONGOING ISSUES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214228 INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-501 00817131020513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening