BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIOS MARATHON H850

    MDR report key: 758689 · Received September 8, 2006

    Report

    Report Number
    1825511-2006-00019
    Event Type
    Other
    Date Received
    September 8, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 8, 2006
    Manufacturer
    PURITAN-BENNETT (LOX), CRYOGENIC DIVISION
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. ALL VISIBLE COMPONENTS APPEARED NORMAL. THE NORMAL EVAPORATION RATE, PRIMARY RELIEF VALVE PRESSURE, ECONOMY VALVE PRESSURE AND ALL FLOWS WERE WITHIN SPECIFICATIONS. IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM, THE UNITS WAS FILLED, PLACED IN THE BACKPACK ACCESSORY AND ALLOWED TO OPERATE FOR 10 HOURS IN THE VERTICAL POSITION. SURFACE TEMPERATURES OF THE DEVICE WERE MONITORED THROUGHOUT THE EXERCISE. THE FLOW OUTPUTS REMAINED BETWEEN 1.0 AND 1.1 1PM THROUGHOUT THE EXERCISE. SURFACE TEMPERATURE ON THE LOWER RIGHT FRONT COVER OF THE DEVICE, WHICH WOULD BE DISTAL TO THE PATIENT, DROPPED AND REMAINED BELOW FREEZING AFTER FOUR HOURS OF TESTING REACHING A LOW OF 22 DEGREES. AFTER THREE HOURS, A PATCH OF FROST FORMED IN THIS AREA. THE FROST REMAINED BELOW THE BACKPACK NETTING THROUGHOUT THE EXERCISE. THERE WERE NO VISIBLE SIGNS OF A VAPOR OR LIQUID OXYGEN LEAK. THE UNIT SUCCESSFULLY COMPLETED ALL NON-DESTRUCTIVE FUNCTIONAL AND PERFORMANCE TESTS. THE EXTERNAL FROSTING IS CONSIDERED NORMAL. WE WERE UNABLE TO DUPLICATE CONDITIONS IN WHICH THE PATIENT WOULD RECEIVE INJURIES FROM THE DEVICE IF USED AS INSTRUCTED. THE HOME USE GUIDE WARNS: "DO NOT TOUCH LIQUID OXYGEN OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQUID OXYGEN IS EXTREMELY COLD (-297 DEGREES F/-183 DEGREES C). WHEN TOUCHED, LIQUID OXYGEN, OR PARTS OF THE EQUIPMENT THAT HAVE BEEN CARRYING LIQUID OXYGEN, CAN FREEZE SKIN AND BODY TISSUE." ADDITIONALLY, "ALWAYS KEEP THE H850 PORTABLE IN ONE OF THE FOLLOWING POSITIONS: UPRIGHT, FLAT ON ITS BACK OR ANY POSITION IN BETWEEN. IT IS IMPORTANT TO ALWAYS KEEP THE H850 PORTABLE IN ONE OF THESE POSITIONS OR LIQUID OXYGEN MAY ESCAPE."

    Description of Event or Problem · 1

    IT WAS REPORTED: A PATIENT WAS USING AN H850 PORTABLE LIQUID OXYGEN DEVICE IN CONJUNCTION WITH THE BACKPACK ACCESSORY. THE PATIENT WAS FOUND TO HAVE A 2ND DEGREE BURN ON HER BACK. THREE DAYS LATER, THE PATIENT WAS USING THE DEVICE WITH A SHOULDER BAG AND WAS FOUND TO HAVE A 2ND DEGREE BURN ON THE LEG. THE PATIENT WAS TREATED WITH A TOPICAL OINTMENT FOR THE INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS MARATHON H850 PORTABLE LIQUID OXYGEN SYSTEM BYJ PURITAN-BENNETT (LOX), CRYOGENIC DIVISION H850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention