BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPONENT MONITORING SYSTEM

    MDR report key: 281249 · Received June 9, 2000

    Report

    Report Number
    9610816-2000-00004
    Event Type
    Death
    Date Received
    June 9, 2000
    Date of Event
    May 2, 2000
    Report Date
    May 9, 2000
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT WENT INTO ASYSTOLE. THE NURSE CLAIMS THAT THE COMPONENT MONITORING SYSTEM DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPONENT MONITORING SYSTEM COMPONENT MONITORING SYSTEM DPS AGILENT TECHNOLOGIES DEUTSCHLAND M1176A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death