BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIEMENS

    MDR report key: 543506 · Received August 12, 2004

    Report

    Report Number
    543506
    Event Type
    Death
    Date Received
    August 12, 2004
    Date of Event
    May 29, 2004
    Report Date
    August 12, 2004
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN CARDIAC SURGERY ICU, INTENSIVE CARE UNIT, EXPERIENCING DIFFICULTY FOLLOWING AORTIC VALVE REPLACEMENT SURGERY. PATIENT WAKING UP AND, AT THE SAME TIME, VENTILATOR ALARMING "HIGH PRESSURE." ALARM NOT HEARD BY RESPIRATORY THERAPIST. SUBSEQUENTLY, BLOOD PRESSURE DROPPED AND ALARMED, PATIENT ARRESTED, AND COULD NOT BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS VENTILATOR CBK MAQUET, INC. SERVO 300A *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death OTHER