BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENERATOR, OXYGEN, PORTABLE

    MDR report key: 1853148 · Received September 29, 2010

    Report

    Report Number
    1040777-2010-00003
    Event Type
    Death
    Date Received
    September 29, 2010
    Date of Event
    March 2, 2010
    Report Date
    September 7, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING AN OXYGEN CONCENTRATOR CONTRIBUTED TO AN ADVERSE EVENT. ACCORDING TO THE REPORTER OF THE EVENT, THE CONCENTRATOR MALFUNCTIONED, WHICH LED TO THE PT BEING ADMITTED TO THE HOSPITAL WHERE HE EXPIRED DUE TO CONGESTIVE HEART FAILURE. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AND NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR, OXYGEN, PORTABLE EVERFLO CAW RESPIRONICS, INC. 1020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death