BEUDAMED
    FDA Adverse Event Other Summary report: N

    C1000T

    MDR report key: 1067868 · Received June 19, 2008

    Report

    Report Number
    1825511-2008-00008
    Event Type
    Other
    Date Received
    June 19, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT LABELING WARNS: "KEEP AND USE THIS EQUIPMENT IN AN UPRIGHT POSITION AT ALL TIMES. IF THE STATIONARY OR PORTABLE UNIT IS TURNED OVER, GASEOUS OR LIQUID OXYGEN WILL ESCAPE. SHOULD A LIQUID SPILL OCCUR, VENTILATE THE AREA BY OPENING DOORS AND WINDOWS AND CALL YOUR LIQUID OXYGEN SUPPLIER IMMEDIATELY. RESTORE YOUR PORTABLE TO THE UPRIGHT POSITION, AVOIDING CONTACT WITH COLD PARTS." "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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A PATIENT WAS USING A C1000T PORTABLE LIQUID OXYGEN DEVICE. THE PATIENT LAID THE DEVICE ON HER LAP. A TIME LATER, THE PATIENT NOTICED A WET SPOT ON HER PANTS. LATER THAT SAME DAY, THE PATIENT DISCOVERED A DISCOLORATION ON THE SKIN OF HER LEG. THE AREA WAS TREATED TOPICALLY BY HER HOME NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C1000T PORTALBE LIQUID OXYGEN DEVICE BYJ PLAINFIELD-LOX-RX C1000T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention