BEUDAMED
    FDA Adverse Event Death Summary report: N

    DS-5300W DSCP (DATASCOPE EXPERT)

    MDR report key: 281765 · Received June 7, 2000

    Report

    Report Number
    9611031-2000-00001
    Event Type
    Death
    Date Received
    June 7, 2000
    Report Date
    April 13, 2000
    Manufacturer
    FUKUDA DENSHI CO., LTD
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATASCOPE REPORTED THAT WHILE THE UNIT WAS IN USE ON A PATIENT, THE UNIT, USING 3-LEAD CABLES, GENERATED A 'LEADS OFF' MESSAGE AT THE BEDSIDE MONITOR (EXPERT MONITOR) AND THE CENTRAL STATION (VISA CENTRAL STATION). THE PT HAD EXPIRED. EVEN AFTER ATTACHING THE ADDITIONAL LEADS THE UNIT STILL GENERATED A 'LEADS OFF' MESSAGE RATHER THAN AN ASYSTOLE ALARM. NOTE: THE PT WAS A 'DNR' (DO NOT RESUSCITATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DS-5300W DSCP (DATASCOPE EXPERT) PATIENT MONITOR DSI FUKUDA DENSHI CO., LTD EXPERT (DATASCOPE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death