BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR 45

    MDR report key: 11604267 · Received April 1, 2021

    Report

    Report Number
    3004972304-2021-00005
    Event Type
    Death
    Date Received
    April 1, 2021
    Date of Event
    January 10, 2021
    Report Date
    June 9, 2021
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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. A FIRE MARSHAL REPORT WAS COMPLETED BY THE CHICAGO FIRE DEPARTMENT. THE CONCLUSION OF THE REPORT STATES: IN CONCLUSION THE FIRE ORIGINATED IN THE BEDROOM OF NURSING HOME IN THE COVID-19 AREA AND THE FIRE WAS THE RESULT OF AN OPEN FLAME IGNITING ORDINARY COMBUSTIBLES TO INCLUDE FABRIC AND PLASTIC O2 TUBING. THE CARELESS USE OF SMOKING MATERIALS CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR IN THIS INVESTIGATION. THERE WAS NO FIRE EXTENSION BEYOND THE AREA OF ORIGIN.

    Additional Manufacturer Narrative · 1

    CAIRE IS COORDINATING AN INVESTIGATION OF THE DEVICE WITH A THIRD-PARTY CONSULTANT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THERE WAS A FIRE AT A REHABILITATION FACILITY, THE (B)(6). THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501189 LIBERATOR 45 STATIONARY, LIQUID OXYGEN BYJ CAIRE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death