BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRIDIA

    MDR report key: 632281 · Received September 1, 2005

    Report

    Report Number
    632281
    Event Type
    Death
    Date Received
    September 1, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 1, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING CONTINUOUSLY MONITORED USING THE PHILIPS ACUTE CARE PHYSIOLOGIC MONITORING SYSTEM. THE PATIENT BEGAN TO HAVE DESATURATIONS AND DECREASED RESPIRATORY RATE OVER PERIOD OF TIME. STAFF HAD TURNED OFF ALARM ON BEDSIDE MONITOR WHICH DEACTIVATED ALL THE ALARMS, INCLUDING THE CENTRAL MONITORING AND PAGER SYSTEM SO NO ALARMS WENT OFF. PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRIDIA PHYSIOLOGICAL MONITOR DRT PHILIPS MEDICAL SYSTEMS, INC. M1204A *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Death| R