BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 24913031 · Received April 17, 2026

    Report

    Report Number
    3004672275-2026-00102
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 17, 2026
    Manufacturer
    INOGEN INC.
    Product Code
    CAW
    UDI-DI
    00817131020179
    PMA / PMN Number
    K032818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT IS ESTIMATED. THE UNIT WAS RETURNED FOR EVALUATION ON 30-MAR-2026. THE UNIT RECEIVED A REPORTED SYSTEM ERROR, WHICH WAS UNABLE TO RECORD THE DATA DUE TO SHUT DOWN THE UNIT WITH ERROR 4(B) IT CAUSES VALVE STUCK FEED WASTE MANIFOLD. AND DATA LOGE SHOWS 02 LOW AND SIEVE WARNING DUE TO HIGH PSA-(14). THE ISSUE WAS CAUSED BY LOW COLUMNS EFFICIENCY, THAT INDICATES COLUMNS CONTAMINATION OR ZEOLITE ABSORBED TOO MUCH MOISTURE. DATA LOG SHOWS MULTIPLE 02 ERRORS DUE TO 02 CALIBRATION FAILURE; RECALIBRATED 02 SENSORS. HOUSING TOP AND UIP DAMAGED DUE TO POSSIBLY DROPPED UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S UNIT HAD A SYSTEM ERROR AND WAS NOT OUTPUTTING OXYGEN. TROUBLESHOOTING DID RESOLVE THE ISSUE. AS A RESULT, THE PATIENT WAS OUT OF BREATH AND A HARD TIME BREATHING. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. 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
    973378 INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR INOGEN ONE G4 BLUETOOTH PORTABLE OXYGEN CONCENTRATOR CAW INOGEN INC. IO-400 00817131020179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening