BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 3760686 · Received April 10, 2014

    Report

    Report Number
    1319044-2014-00006
    Event Type
    Death
    Date Received
    April 10, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 9, 2014
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING HELD FOR EVALUATION AFTER THE CAUSE OF THE FIRE HAS BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE SENT ONCE THE FIRE CAUSE HAS BEEN DETERMINED AND THE DEVICE CAN BE EVALUATED.

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION OF A FIRE DAMAGING 2 CONDOMINIUMS AND A WOMAN'S DEATH. THE WOMAN HAD AN OXYGEN CONCENTRATOR IN HER CONDO AND AT THIS TIME IS UNKNOWN IF IT'S RELATED TO THE FIRE. THE FIRE IS BEING INVESTIGATED BY THE LOCAL FIRE MARSHAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216370 NEWLIFE ELITE CAW AIRSEP CORP. AS005-1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death