BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOSET CS - A - EUR1

    MDR report key: 4906040 · Received July 2, 2015

    Report

    Report Number
    3007573469-2015-00237
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    October 16, 2013
    Report Date
    July 1, 2015
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A PATIENT SUFFERED CARDIAC ARREST IN A CONVALESCENT CENTER. THE PATIENT RECEIVED CPR FROM THE STAFF IMMEDIATELY AND WAS BROUGHT BY AMBULANCE TO THE HOSPITAL, HOWEVER, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND DIED IN HOSPITAL. PER THE REPORTER, THE PATIENT DEATH HAS BEEN ASCRIBED TO THE SEVERITY OF HIS MEDICAL CONDITION (ADHF: ACUTE DECOMPENSATED HEART FAILURE) AND ADVANCED AGE. MFR#: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433298 AUTOSET CS - A - EUR1 VENTILATOR, NON-CONTINUOUS BZD RESMED LTD 36211

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death