BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 1525875 · Received November 6, 2009

    Report

    Report Number
    1825511-2009-00007
    Event Type
    Injury
    Date Received
    November 6, 2009
    Date of Event
    August 31, 2009
    Report Date
    October 8, 2009
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. AT THE TIME OF THE EVENT, THE PT HAD FIVE LIQUID OXYGEN DEVICES IN THE HOME. IT IS NOT KNOW WHICH UNIT OR UNITS WERE INVOLVED IN THE EVENT, THEREFORE, ALL FIVE ARE BEING REPORTED. REFERENCE MEDWATCH REPORTS: 1825511-2009-00005, 1825511-2009-000006, 1825511-2009-000008, AND 1825511-2009-00009. PRODUCT USER MANUAL 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." ADDITIONALLY, "CLEAN AND DRY THE FILL CONNECTORS ON BOTH THE STATIONARY AND PORTABLE UNITS TO PREVENT FREEZING AND POSSIBLE EQUIPMENT FAILURE."

    Description of Event or Problem · 1

    IT WAS REPORTED: A PT WAS FILLING A C1000 PORTABLE DEVICE FROM A C31 STATIONARY DEVICE. AT THE END OF THE FILL PROCESS, THE PT WAS UNABLE TO SEPARATE THE TWO DEVICES. LIQUID OXYGEN THEN ESCAPED FROM THE CONNECTION AND RAN DOWN THE SIDE OF THE STATIONARY UNIT TO THE CARPET. THE PT SUSTAINED THERMAL INJURIES TO HIS LEFT FOOT REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 1000 PORTABLE LIQUID OXYGEN SYSTEM BYJ PLAINFIELD-LOX-RX C1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention| S