BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL HELIOS 46 RESERVOIR

    MDR report key: 916808 · Received September 15, 2007

    Report

    Report Number
    1825511-2007-00013
    Event Type
    Death
    Date Received
    September 15, 2007
    Report Date
    August 15, 2007
    Manufacturer
    PURITAN-BENNETT (LOX), CRYOGENIC DIVISION
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. THE SERIAL NUMBER AND PHYSICAL LOCATION OF DEVICE ARE NOT KNOWN. BASED ON THE AVAILABLE INFORMATION, IT APPEARS THE INCIDENT OCCURRED DUE TO A FLOW CONTROL VALVE NOT BEING UTILIZED, CONTRARY TO THE INSTRUCTIONS FOR USE. IF A FLOW CONTROL VALVE WAS NOT UTILIZED THE OXYGEN FLOW WOULD EXCEED 10 LPM. PRODUCT LABELING WARNS, "WARNING-DO NOT EXCEED 10 L/MIN MAXIMUM FLOW." LABELING ALSO STATES, "READ PATIENT OPERATING INSTRUCTIONS." PRODUCTS OPERATING INSTRUCTIONS EXPLAIN THE USE OF A FLOW CONTROL VALVE AND WARNS, "DO NOT TOUCH LIQUID OXYGEN OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQUID OXYGEN IS EXTREMELY COLD (-297 DEGREES FAHRENHEIT/-183 DEGREES CELSIUS). WHEN TOUCHED, LIQUID OXYGEN, OR PARTS OF THE EQUIPMENT THAT HAVE BEEN CARRYING LIQUID OXYGEN, CAN FREEZE SKIN AND BODY TISSUE." WE ARE COORDINATING WITH THE HEALTHCARE FACILITY TO PROVIDE ADDITIONAL STAFF TRAINING ON THE PROPER USE OF LIQUID OXYGEN PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS ATTACHED TO A U46 LIQUID OXYGEN RESERVOIR. A FLOW CONTROL VALVE ACCESSORY WAS NOT UTILIZED. THE PATIENT EXPIRED APPROXIMATELY 24 HOURS LATER. FROST WAS NOTED ON THE OXYGEN SUPPLY TUBING AND THE PATIENT'S FACE. THE CAUSE OF DEATH IS NOT KNOWN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death