BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOSET CS - A - EUR1

    MDR report key: 4906029 · Received July 2, 2015

    Report

    Report Number
    3004604967-2015-00237
    Event Type
    Death
    Date Received
    July 2, 2015
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K113801
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEATH OCCURRED OUTSIDE THE US AND AT THE TIME OF THE EVENT ((B)(6) 2013) WAS ASSESSED BY RESMED AND DEEMED NOT REPORTABLE. THIS DECISION WAS BASED ON THE PATIENT'S UNDERLYING CONDITION, THE PATIENT WAS NOT USING THE DEVICE AT THE TIME OF DEATH, AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. RECENT PRELIMINARY DATA FROM THE SERVE-HF CLINICAL TRIAL INDICATED AN INCREASED RISK OF CARDIOVASCULAR DEATHS IN PATIENTS WITH SYMPTOMATIC, CHRONIC HEART FAILURE (NYHA 2-4) WITH REDUCED LEFT VENTRICULAR EJECTION FRACTION (LVEF LESS THAN AND EQUAL TO 45 PERCENT) AND MODERATE TO SEVERE PREDOMINANT CENTRAL SLEEP APNEA BEING TREATED WITH ADAPTIVE SERVO-VENTILATION (ASV). NOTE: FURTHER INFORMATION REGARDING THE TRIAL AND REMEDIAL ACTION CAN BE FOUND IN MEDWATCH 3004604967-2015-00176. IN LIGHT OF THIS NEW INFORMATION RESMED HAS EXAMINED HISTORICAL COMPLAINTS RECORDS RELATED TO ASV THERAPY TO DETERMINE IF DECISIONS PREVIOUSLY REACHED REQUIRE REVISION BASED ON THIS NEW INFORMATION. THIS EVENT IS BEING REPORTED BASED ON THE NEW INFORMATION FROM THE CLINICAL TRIAL AND THE INFORMATION PROVIDED TO RESMED REGARDING THIS EVENT. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433309 AUTOSET CS - A - EUR1 VENTILATOR, NON-CONTINUOUS BZD RESMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1