BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE

    MDR report key: 1983843 · Received February 7, 2011

    Report

    Report Number
    1319044-2011-00005
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    October 1, 2009
    Report Date
    February 5, 2011
    Manufacturer
    AIRSEP CORPORATION
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING HELD IN (B)(6). ARRANGEMENTS ARE BEING MADE TO EXAMINE THE OXYGEN CONCENTRATOR. A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LETTER RECEIVED FROM ATTORNEY STATES: "SPECIFICALLY, MR. (B)(6) SUFFERED BURNS THAT ULTIMATELY LEAD TO HIS DEATH WHILE USING YOUR PRODUCT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death