BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE LIBERATOR 60

    MDR report key: 2042007 · Received March 31, 2011

    Report

    Report Number
    3004822415-2011-00006
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    October 6, 2010
    Report Date
    February 24, 2011
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, CAIRE RECEIVED INFO OF AN ALLEGED INCIDENT THAT TOOK PLACE ON (B)(6) 2010. ON THE DAY OF THE ALLEGED INCIDENT, THE PT ("C.G.") ATTEMPTED TO FILL A SMALL PORTABLE LIQUID OXYGEN TANK TO A BASE LIBERATOR TANK, WHEN THE TWO UNITS ALLEGEDLY BECAME STUCK TOGETHER. WHEN THE PT TRIED TO CLOSE THE FILL LEVER, THE UNIT(S) LEAKED LIQUID OXYGEN. AFTER UNSUCCESSFUL ATTEMPTS OF PRESSING THE RELEASE BUTTON ON THE LIBERATOR BASE UNIT, THE PT CALLED HIS PROVIDER (LEASOR OF THE UNIT). THE PROVIDER TECHNICIAN ARRIVED AT THE PT'S HOME; NOTING A MIST IN THE HOME, THAT THE FLOOR WAS WET, AND THE PT WAS BAREFOOT. THE PT ALLEGES SECOND DEGREE BURNS AND FROSTBITE TO THE TOES ON HIS LEFT FOOT, AS A RESULT OF THE INCIDENT. THE UNIT PROVIDER STATED THAT THE INVOLVED UNITS WERE INSPECTED AT THEIR FACILITY AND ARE FULLY FUNCTIONAL UNITS. THE PROVIDER ALSO STATED THAT THE INVOLVED UNITS ARE NOW ISSUED TO A NEW PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE LIBERATOR 60 BYJ UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE, INC. 13263811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other