BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 1813594 · Received August 17, 2010

    Report

    Report Number
    1319044-2010-00014
    Event Type
    Death
    Date Received
    August 17, 2010
    Date of Event
    March 24, 2010
    Report Date
    August 17, 2010
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRESENTLY COORDINATING A DATE FOR EXAMINATION OF FIRE SCENE AND DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED AN INJURY/DEATH IN A FIRE RELATED TO THE USE OF A NEWLIFE ELITE OXYGEN CONCENTRATOR. INCIDENT OCCURRED IN (B)(6). THE DEVICE AND FIRE SCENE HAVE BEEN PRESERVED FOR INSPECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death