BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWLIFE ELITE

    MDR report key: 3022560 · Received March 22, 2013

    Report

    Report Number
    1319044-2013-00003
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DIED OF A HEART ATTACK AND HIS WIFE IS BLAMING IT ON THE NEWLIFE OXYGEN CONCENTRATOR HE WAS USING THAT NIGHT WHILE SLEEPING, BECAUSE THE FLOW WAS A 1 LPM INSTEAD OF THE 4 LPM PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119775 NEWLIFE ELITE OXYGEN CONCETRATOR CAW AIRSEP CORP. AS005-4U

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death