BEUDAMED
    FDA Adverse Event Death Summary report: N

    HP AGILIENT OMNICARE VIRIDIA CMS

    MDR report key: 572961 · Received February 8, 2005

    Report

    Report Number
    572961
    Event Type
    Death
    Date Received
    February 8, 2005
    Date of Event
    January 29, 2005
    Report Date
    February 8, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    RN WENT TO PATIENT'S BEDSIDE TO CHECK IV. FOUND PATIENT APNEIC AND WITHOUT A PULSE. NEITHER THE BEDSIDE ALARM NOR THE CENTRAL STATION ALARM ACTIVATED. CPR STARTED IMMEDIATELY WITHOUT SUCCESS. PATIENT SUBSEQUENTLY PRONOUNCED DEAD. EQUIPMENT WAS CHECKED BY BOTH PHILIPS AND BIOMEDICAL ENGINEER AND COULD NOT DUPLICATE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HP AGILIENT OMNICARE VIRIDIA CMS PHYSIOLOGICAL MONITOR MHX PHILIPS MEDICAL SYSTEMS, INC. M1175A *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death