BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL HELIOS 46 RESERVOIR

    MDR report key: 666281 · Received January 20, 2006

    Report

    Report Number
    1825511-2006-00001
    Event Type
    Death
    Date Received
    January 20, 2006
    Date of Event
    December 19, 2005
    Manufacturer
    PURITAN BENNETT (LOX) CRYOGENIC DIVISION
    Product Code
    BYJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOME CARE PROVIDER (HCP) REPORTED THE FOLLOWING INFO: A HOSPICE PT, PRESCRIBED 10 LPM, WAS PLACED ON A NON-REBREATHER MASK THAT WAS ATTACHED TO A U46 RESERVOIR. A FLOW CONTROL VALVE WAS NOT UTILIZED. THE PT WAS LEFT UNATTENDED ON THIS CONFIGURATION FOR SEVERAL HOURS. FROST DEVELOPED ON THE SUPPLY TUBING AND MASK. PT WAS FOUND TO HAVE EXPIRED AROUND MIDNIGHT. CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HELIOS 46 RESERVOIR LIQUID OXYGEN SYSTEM BYJ PURITAN BENNETT (LOX) CRYOGENIC DIVISION U46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death