BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS 46 RESERVOIR

    MDR report key: 721123 · Received May 26, 2006

    Report

    Report Number
    1825511-2006-00013
    Event Type
    Injury
    Date Received
    May 26, 2006
    Date of Event
    January 1, 2006
    Report Date
    April 25, 2006
    Manufacturer
    PURITAN BENNETT (LOX)
    Product Code
    BYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT USING AN H46 RESERVOIR COMPLAINED OF NOT RECEIVING FLOW FROM THE UNIT. THE LOSS OF FLOW WAS CONFIRMED VIA FLOWMETER. THE PT REQUIRED MEDICAL ATTENTION AS A RESULT OF THE INDICENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS 46 RESERVOIR RESERVOIR LIQUID OXYGEN SYSTEM BYJ PURITAN BENNETT (LOX) H-46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN