BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS MEDICAL INC.

    MDR report key: 602621 · Received May 12, 2005

    Report

    Report Number
    602621
    Event Type
    Death
    Date Received
    May 12, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 11, 2005
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WITH PERMANENT PACEMAKER BEING MONITORED ON CARDIAC STEPDOWN UNITS. SINCE ADMISSION IN 2005, CARDIAC TRACINGS INDICATE APPROPRIATE CAPTURE OF PACEMAKER WHEN RATE INDICATES. THE 5TH DAY AT APPROXIMATELY 6:30 PM, PT FOUND UNRESPONSIVE BY FAMILY. PT WAS CODED FOR 19 MINUTES AND PRONOUNCED DEAD. NO AUDIBLE ALARMS NOTED AT CENTRAL MONITORING STATION. STRIPS PULLED FROM EVENT LOG NOTE PACER SPIKE WITH NO COMPLEX FOLLOWED BY CARDIAC STANDSTILL. THIS WAS INTERPRETED MY MONITOR AS "PAUSE". PAUSE IS NOT DEFINED AS AN ALARMABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS MEDICAL INC. CENTRAL STATION MONITOR DRT SPACELABS MEDICAL INC. 90385 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death