BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS MARATHON H850EU

    MDR report key: 981439 · Received January 11, 2008

    Report

    Report Number
    1825511-2008-00002
    Event Type
    Injury
    Date Received
    January 11, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 10, 2007
    Manufacturer
    PLAINFIELD -LOX
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND IS UNDERGOING EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED WITH OUR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A PT PLACED A PORTABLE LIQUID OXYGEN DEVICE IN HER PURSE, IN THE HORIZONTAL POSITION. THE PURSE WAS THEN PLACED ON HER LAP. AFTER 45 MINUTES, THE PT FELT COLD ON HER LEG, BUT DID NOT REMOVE THE PURSE FROM HER LAP. AFTER 2 HOURS THE PT REMOVED HER PURSE AND DISCOVERED ICE ON HER PANTS. REPORTEDLY, THE PT RECEIVED TREATMENT FOR THERMAL INJURY TO HER LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS MARATHON H850EU PORTABLE LIQUID OXYGEN DEVICE BYJ PLAINFIELD -LOX H850EU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention