BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 22524989 · Received July 16, 2025

    Report

    Report Number
    3004672275-2025-00099
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 16, 2025
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION ON 26-JUN-2025. THE UNIT WAS RECEIVED WITH A SYSTEM ERROR, WHICH WAS CONFIRMED UPON INSPECTION. THE FEED WASTE MANIFOLD VALVE WAS FOUND TO BE STUCK DUE TO INTERNAL DEBRIS, WHILE THE FEED PORT WAS BLOCKED, AND THE ZEOLITE WAS CONTAMINATED FROM EXCESSIVE MOISTURE ABSORPTION. THIS COMBINED ISSUE STUCK VALVE, BLOCKED FEED PORT, AND CONTAMINATED ZEOLITE LED TO A SYSTEM ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DAUGHTER HAD REPORTED THAT THE UNIT STARTED VIBRATING AND MAKING A LOUD NOISE IN THE MIDDLE OF THE NIGHT. THERE WAS A BURNING SMELL AND A SYSTEM ERROR CODE WAS BEING DISPLAYED. AS A RESULT, THE PATIENT WAS RUSHED TO THE HOSPITAL. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553597 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 Hospitalization