BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS H36

    MDR report key: 1990652 · Received February 8, 2011

    Report

    Report Number
    3004822415-2011-00004
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    March 5, 2010
    Report Date
    March 19, 2010
    Manufacturer
    CAIRE, INC.
    Product Code
    CAW
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT UNIT WAS RETURNED TO COVIDIEN (B)(6), AND THE RESULTS FROM THEIR INSPECTION WERE GIVEN ON (B)(4), 2010. THE SUBJECT UNIT PASSED VALVE, LEAK, REGULATOR, PRESSURE, AND FLOW TESTS. IT WAS DETERMINED THAT THE SUBJECT UNIT WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE ALLEGED EVENT TOOK PLACE ON (B)(6), 2010, IN (B)(6). THE ALLEGED EVENT IS DESCRIBED AS THE FOLLOWING: "AFTER THREE HOURS OF USING THE UNIT, IT WAS REPORTED THAT IT STOPPED PROVIDING OXYGEN WHILE BEING USED ON A PT IN THE PT'S HOME. FOLLOWING, THE PT'S CONDITION DETERIORATED AND THEY WERE IMMEDIATELY ADMITTED TO THE HOSPITAL BECAUSE OF HYPOXEMIA. THE PT HAS FULLY RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS H36 LIQUID OXYGEN, STATIONARY RESERVOIR CAW CAIRE, INC. B-702034-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other