BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPANION 5

    MDR report key: 19964481 · Received August 12, 2024

    Report

    Report Number
    3004972304-2024-00009
    Event Type
    Death
    Date Received
    August 12, 2024
    Date of Event
    July 7, 2024
    Report Date
    August 12, 2024
    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 WILL NOT BE AVAILABLE FOR ENGINEERING EVALUATION AND THE AVAILALBE EVIDENCE INDICATES CONFIRMED USE ERROR. THE END USER REPORTED FALLING ASLEEP WHILE SMOKING A CIGARETTE AND 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 FELL ASLEEP WHILE SMOKING WITH OXYGEN ON, IGNITING OXYGEN. PATIENT SUSTAINED GRADE THREE INHALATION BURNS AND ADDITIONAL PARTIAL THICKNESS BURNS TO HANDS AND FEET. SOOT NOTED THROUGH THE MOUTH AND NOSE, AND BILATERAL CORNEAL ABRASIONS. PATIENT TAKEN TO TRANSFERRED TO ORLANDO REGIONAL MEDICAL CENTER BURN UNIT. PATIENT IS CURRENTLY INTUBATED WITH VENTILATOR SUPPORT. UPDATED 17 JULY: PATIENT DEATH DATE (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293749 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005 M766150670050

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| L| D