BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW LIFE INTENSITY 10

    MDR report key: 19968073 · Received August 12, 2024

    Report

    Report Number
    3004972304-2024-00002
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    March 28, 2024
    Report Date
    August 12, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    UDI-DI
    M766AS0991010
    PMA / PMN Number
    K960309
    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.

    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 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.

    Description of Event or Problem · 0

    AS REPORTED: PATIENT ATTEMPTED TO SMOKE WHILE WEARING HIS OXYGEN AND SUSTAINED SECOND DEGREE BURNS TO BILATERAL NARES. HE WENT TO BED AND WOKE UP AT 4AM HAVING DIFFICULTY BREATHING AND CALLED 911 TO TAKE HIM TO THE HOSPITAL FOR TREATMENT. PATIENT IS A KNOWN SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246276 NEW LIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-100 M766AS0991010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization