BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 5

    MDR report key: 18231149 · Received November 29, 2023

    Report

    Report Number
    3004972304-2023-00018
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 6, 2023
    Report Date
    July 26, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    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 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.

    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**.

    Description of Event or Problem · 0

    AS REPORTED: PATIENT WAS SITTING IN HER DINING ROOM WITH HER OXYGEN ON AND WAS SMOKING A CIGARETTE, WHICH CAUSED A FLASH FIRE TO HER FACE. PATIENT'S FAMILY SMELLED SMOKE AND RAN TO FIND THE PATIENT. FAMILY PUT OUT THE FLAMES WITH A WET CLOTH. PATIENT'S CAREGIVER CALLED 911 AND THE HOSPICE NURSE WHO WENT TO THE HOME. NURSE FACETIMED WITH HOSPICE DOCTOR WHILE AWAITING EMS. EMS ARRIVED AND PATIENT WAS AIR FLIGHTED TO (B)(6) CENTER FOR TREATMENT. PATIENT WAS DIAGNOSED WITH PARTIAL THICKNESS BURNS TO THE FOREHEAD NOSE AND LEFT ASPECT OF THE NECK. PATIENT IS ADMITTED TO HOSPICE WITH A PRIMARY DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE A RELATED DIAGNOSIS OF DYSPNEA AND AN UNRELATED DIAGNOSIS OF HYPERLIPIDEMIA. PATIENT HAS DENIED THAT SHE IS A SMOKER TO HOSPICE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982794 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Life Threatening| H