BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 1680765 · Received May 11, 2010

    Report

    Report Number
    1319044-2010-00006
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    April 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    AIRSEP CORPORATION
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING EVALUATED BY AIRSEP CORPORATION AND THE (B) (6) IN (B) (6), ON MAY 13, 2010.

    Description of Event or Problem · 1

    INCIDENT INVOLVING THE DEATH OF A HOME OXYGEN PT IN A HOUSE FIRE, THE CAUSE OF WHICH IS UNK YET. EX-SMOKER WITH COPD. PT PUT TO BED AT 10:30 PM, ALL WAS WELL. AT 6:15 AM, THE OTHER OCCUPANTS OF THE HOUSE WERE WOKEN TO A HISSING SOUND AND PT CRYING FOR HELP. THEY TRIED TO ENTER THE DOWNSTAIRS ROOM WHICH WAS ON FIRE AND PT RECEIVED SIGNIFICANT BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWLIFE ELITE OXYGEN CONCENTRATOR CAW AIRSEP CORPORATION AS005-232

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death