BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRIDIA CMS

    MDR report key: 289028 · Received August 7, 2000

    Report

    Report Number
    289028
    Event Type
    Death
    Date Received
    August 7, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 4, 2000
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN MICU. PT WENT INTO LETHAL DYSRHYTHMIA (V-TACH, V-FIB). LETHAL ALARM AND PRINTOUT DID NOT FUNCTION. CODE WAS NOT CALLED FOR SEVERAL MINUTES. PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRIDIA CMS CARDIAC MONITORING SYSTEM DSI AGILENT TECHNOLOGIES M1046B *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death