BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN ONE G4

    MDR report key: 24429041 · Received February 23, 2026

    Report

    Report Number
    MW5184296
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    January 24, 2026
    Report Date
    February 18, 2026
    Manufacturer
    INOGEN, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'M A CPAP + O2 PATIENT UNDER 8-YEARS OF REGULAR CARE BY A LICENCED PULMONOLOGIST. WITH OFFICIAL RX, I PURCHASED AN INOGEN ONE G4 FROM (B)(6), ON (B)(6) 2024. I USED THE UNIT INTERMITTENTLY (SIEVE COLUMNS SN (B)(6), THE FIRST TWO NUMBERS SIGNIFY THE YEAR OF ASSEMBLY) FOR NEARLY 2 YEARS WITHOUT ANY PROBLEMS. AROUND (B)(6) 2026, THE UNIT INDICATED THE SIEVE COLUMNS NEEDED TO BE REPLACED. I PURCHASED THE COLUMNS (SN (B)(6)) FROM MCS, INSTALLED THEM, AND USED THEM ON (B)(6) 2026. WITHIN 30-40 MINUTES, I BECAME DIZZY, WITH FLU-LIKE SYMPTOMS, AND LUNG IRRITATION. IN MY 8 YEARS OF SUPPLEMENTAL O2 USE, I HAVE NEVER EXPERIENCED ANYTHING SIMILAR. I CONTACTED ((B)(6) TECHNICAL SUPPORT) TO REPORT MY ADVERSE EXPERIENCE. HE SUGGESTED I RETURN MY G4 UNIT FOR INSPECTION. THEY REFURBISHED THE UNIT AND RETURNED IT ON APPROXIMATELY (B)(6) 2026. I TRIED IT AGAIN AND HAD THE SAME BAD EXPERIENCE. I NOTIFIED HIM AGAIN, AND HE SENT ME A SECOND PAIR OF COLUMNS (SN (B)(6)). I INSTALLED THESE REPLACEMENTS AND, ONCE AGAIN, HAD AN ADVERSE EXPERIENCE. I OWN TWO (2) INOGEN AT HOME OXYGEN CONCENTRATORS AND HAVE NOT EXPERIENCED THESE TYPES OF ADVERSE SYMPTOMS. I AM A RETIRED PROFESSIONAL WITH AN INVESTIGATIVE MIND AND WITH BASIC KNOWLEDGE OF THIS MEDICAL EQUIPMENT. THERE'S A POSSIBILITY THAT THE SIEVE COLUMNS ASSEMBLED IN 2025 ARE CONTAMINATED. GIVEN THE FACT THAT INOGEN ENTERED INTO A "PARTNERSHIP" ARRANGEMENT WITH THE CHINESE COMPANY, JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY COMPANY ("YUWELL") IN JANUARY 2025 (SEE INTERNET), MY EXPERIENCE AND LIMITED INVESTIGATION SUGGEST ZEOLITE CONTAMINATION EITHER FROM THE CHINESE MATERIALS SUPPLIER OR IN THE "ASSEMBLY PROCESS" HERE IN THE US. UNDERSTANDABLY, MCS HAS NO ULTIMATE SOLUTION. TODAY, (B)(6) 2026, MCS SUGGESTED SWAPPING OUT MY G4 FOR ANOTHER REFURBISHED UNIT. I AGREED, SINCE I DON'T KNOW WHAT TO DO. MY DECLINING HEALTH AND FRUSTRATION MOTIVATED ME TO FILE THIS 3500B REPORT. (B)(6). HEALTH CODE: 1849, 1858, 2194, 2421. DEVICE CODE: 2993. REFERENCE REPORT# MW5184297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484588 INOGEN ONE G4 GENERATOR, OXYGEN, PORTABLE CAW INOGEN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| O