BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRALSCOPE MONITORING SYSTEM

    MDR report key: 34304 · Received June 28, 1996

    Report

    Report Number
    34304
    Event Type
    Death
    Date Received
    June 28, 1996
    Date of Event
    June 17, 1996
    Report Date
    June 28, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITHOUT HEART RHYTHM WHILE ON HEART MONITOR. HEART MONITOR DID NOT ALARM TO IDENTIFY THAT PT WAS WITHOUT A HEART RHYTHM. PT HAD A PACEMAKER. IT IS BELIEVED THAT THE MONITOR COUNTED THE PACER SPIKES AS IF IT WERE A HEART RHYTHM AND DID NOT IDENTIFY A NEED FOR AN ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRALSCOPE MONITORING SYSTEM MONITORING SYSTEM DRT MARQUETTE ELECTRONICS, INC. MUCNSCP

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death