BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW LIFE INTENSITY 10

    MDR report key: 19209585 · Received April 29, 2024

    Report

    Report Number
    3004972304-2024-00001
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    March 26, 2024
    Report Date
    August 12, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    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. **UDI RELATED DATA QUALITY UPDATES ONLY** SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2016.

    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 WAS SMOKING WITH OXYGEN ON AND SUSTAINED SECOND DEGREE BURNS TO HIS FACE. PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND TREATMENT. PATIENT IS A KNOWN SMOKER AND LIT A CIGARETTE WHILE INTOXICATED CAUSING A FLAME THAT BURNED HIS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305996 NEW LIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization