BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25124454 · Received May 8, 2026

    Report

    Report Number
    3004672275-2026-00127
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 8, 2026
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    UDI-DI
    00817131020414
    PMA / PMN Number
    K222086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE UNIT RECEIVED A REPORTED SYSTEM ERROR, WHICH WAS CONFIRMED THROUGH THE DATA LOG AND DIAGNOSTIC PAGE SHOWS 02 INTERNAL LOW (81 .2%) AND EXTERNAL 02 READING SERV0MEX (79%). THE ISSUE WAS CAUSED BY CONTAMINATED ZEOLITE, INDICATING THAT THE ZEOLITE ABSORBED EXCESSIVE MOISTURE. THE PSA CYCLE COUNT WAS 16. THE DATA LOG SHOWS LOW BATTERY ERRORS; THIS MEANS THE PATIENT RUNNING THE UNIT ON LOW BATTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE SYSTEM ERROR MESSAGE AND THEIR BATTERY KEPT BEEPING WHEN THEY WERE OUTSIDE. AS A RESULT, THE PATIENT STARTED EXPERIENCING SHORTNESS OF BREATH. 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
    424616 INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR INOGEN ROVE 4 PORTABLE OXYGEN CONCENTRATOR CAW INOGEN, INC. IO-401 00817131020414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening