BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G5 PORTABLE OXYGEN CONCENTRATOR

    MDR report key: 25191164 · Received May 15, 2026

    Report

    Report Number
    3004672275-2026-00134
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 15, 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
    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 WAS RETURNED WITH REPORTED SYSTEM HOT, WHICH WAS NOT CONFIRMED UPON INSPECTION PRODUCT MANIFOLD LEAK AND MUFFLER WAS BLOCKED WITH DUST, IT CAUSES LOW FLOW. INTERNAL 02 READING MEASURED 70%, WHILE THE EXTERNAL 02 READING MEASURED 67%. HIGH PSA INDICATES COLUMNS ARE CONTAMINATED WITH MOISTURE, LEAK PIM AND BLOCKED MUFFLER, ALL ARE CONTRIBUTED TO THE LOW OXYGEN LEVEL. HOUSING & UIP WAS DIRTY & SCRATCHED DUE TO PROBABLE ROUGH CLEANING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS OVERHEATING AND SHUTTING OFF. TROUBLESHOOTING SHOWED NO COLUMN ISSUES. IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVEL HAD DECREASED TO 88%. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT. 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
    132610 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 Life Threatening