BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENNIUM OXYGEN CONCENTRATOR

    MDR report key: 1680714 · Received May 10, 2010

    Report

    Report Number
    1040777-2010-00002
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    April 27, 2007
    Report Date
    April 16, 2010
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    CAW
    PMA / PMN Number
    K972614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION OR IF PERTINENT ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    ON 04/16/2010, WE WERE NOTIFIED BY A LEGAL CLAIM THAT A FIRE ORIGINATED IN THE PRESENCE OF A MILLENNIUM OXYGEN CONCENTRATOR. ACCORDING TO THE CLAIM, A LAMP, RADIO/STEREO AND THE OXYGEN CONCENTRATOR WERE PLUGGED INTO A POWER STRIP LOCATED IN THE LIVING ROOM OF THE PT'S RESIDENCE. ACCORDING TO THE CLAIM, THE EQUIPMENT PLUGGED INTO THE POWER STRIP CAUSED THE POWER STRIP TO OVERLOAD AND INITIATE THE FIRE. ON (B) (6) 2007, A FIRE IGNITED INSIDE THE PT'S RESIDENCE IN THE NORTHEAST CORNER OF THE LIVING ROOM. THE FIRE SEVERELY DAMAGED THE HOUSE. THE CLAIMS STATES THE PT INHALED PRODUCTS OF COMBUSTION AND SUFFERED BURNS. WHEN EMERGENCY RESCUE PERSONNEL ARRIVED AT THE RESIDENCE, THEY WERE MET BY HEAVY FIRE AND SMOKE FROM THE FRONT OF THE HOUSE. THE PT WAS FOUND IN A LIFELESS STATE ON THE BED IN THE BEDROOM DIRECTLY ACROSS FROM THE LIVING ROOM. SHE WAS PRONOUNCED DEAD AT THE SCENE. IT IS NOT KNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT OR IF THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM OXYGEN CONCENTRATOR GENERATOR, OXYGEN PORTABLE CAW PHILIPS RESPIRONICS 600

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death