BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 5

    MDR report key: 24408161 · Received February 20, 2026

    Report

    Report Number
    3004972304-2026-00001
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 4, 2026
    Report Date
    February 20, 2026
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    UDI-DI
    M766150670050
    PMA / PMN Number
    K121167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE INFORMATION PROVIDED REPRESENTS THE BEST INFORMATION AVAILABLE TO CAIRE. THE DEVICE(S) WILL NOT BE AVAILABLE FOR ENGINEERING EVALUATION. THE END USER REPORTED SMOKING A CIGARETTE WHILE USING THE OXYGEN CONCENTRATOR DEVICE. NO SMOKING WARNINGS ON THE EQUIPMENT AND IN THE IFU WERE REVIEWED AND DEEMED ADEQUATE IN THE COURSE OF THE INVESTIGATION. "NO SMOKING" SYMBOLS (REG# P002) ARE AFFIXED TO THE FACE OF THE UNITS. THROUGHOUT THE UNIT IFU, WARNINGS STATE NOT TO ALLOW SMOKING OR OPEN FLAME NEAR THE DEVICE AND TO KEEP ALL FLAMMABLE MATERIALS AWAY FROM THE EQUIPMENT. ADDITIONAL WARNINGS STATE THAT SMOKING WHILE WEARING AN OXYGEN CANNULA CAN CAUSE FACIAL BURNS AND POSSIBLY RESULT IN DEATH. COMPANION 5 RISK ANALYSIS (B)(4) REV M WAS REVIEWED AND FOUND TO BE ADEQUATE WITHOUT REVISION.

    Description of Event or Problem · 0

    AS REPORTED TO CAIRE: PATIENT WAS SMOKING WITH OXYGEN ON IGNITING OXYGEN CANNULA. PATIENT SUSTAINED 2ND DEGREE URNS TO NARES, LEFT CHEEK, AND LIPS WHICH ARE SCABBED OVER. PATIENT HAD FLUID TO LEFT WRIST AND MIDDLE FINGER FROM THIS INCIDENT. PATIENT RECEIVED TREATMENT IN ER TO INCLUDE A TETANUS INJECTION, MORPHINE AND BACITRACIN TO NARES. PATIENT RETURNED HOME AFTER ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74154 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005 M766150670050

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization