BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR 45

    MDR report key: 9578328 · Received January 10, 2020

    Report

    Report Number
    3004972304-2020-00001
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    November 11, 2019
    Report Date
    January 10, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PRAXAIR RECEIVED A CALL FROM THE NURSE. THEY NOTICED THAT THE LIBERATOR WAS FREEZING, AND THE OXYGEN CANNULA EXPLODED DUE TO HIGH PRESSURE. THE CANNULA HAD LIQUID OXYGEN, CAUSING SECOND DEGREE BURNS TO THE PATIENT'S THROAT AND FACE. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR EMERGENCY ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36978 LIBERATOR 45 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13262261

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization