BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRAL MONITOR SYSTEM

    MDR report key: 34102 · Received June 19, 1996

    Report

    Report Number
    34102
    Event Type
    Death
    Date Received
    June 19, 1996
    Date of Event
    May 31, 1996
    Report Date
    June 17, 1996
    Manufacturer
    HEWLETT PACKARD CO.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD EPICARDIAL PACING WIRES CONNECTED TO EXTERNAL PACEMAKER GENERATOR. THE PT WAS BEING MONITORED VIA CO ARRHYTHMIA MONITORING SYSTEM. AT APPROX 0425 THE NURSE OBSERVED THE PT TO DEMONSTRATE A CHANGE IN RHYTHM. THE ARRHYTHMIA MONITORING SYSTEM PROVIDED NO AUDIBLE ALARM BASED ON THE RHYTHM CHANGE. ASSESSMENT OF THE PT REVEALED A STATE OF CARDIAC ARREST. REVIEW OF THE MONITORED RHYTHM DEMONSTRATED PACEMAKER SPIKES WITHOUT ANY CAPTURE (QRS). ARRHYTHMIA MONITORING SYSTEM DID NOT IDENTIFY THE RHYTHM CHANGE AS "PACE NOT CAPTURE" OR "ASYSTOLE" WHICH WOULD HAVE PROVIDED AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL MONITOR SYSTEM CENTRAL MONITOR SYSTEM DRT HEWLETT PACKARD CO. 2360A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death