BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARQUETTE

    MDR report key: 363630 · Received November 30, 2001

    Report

    Report Number
    363630
    Event Type
    Death
    Date Received
    November 30, 2001
    Date of Event
    November 24, 2001
    Report Date
    November 28, 2001
    Manufacturer
    GE MARQUETTE MEDICAL SYSTEMS, QA
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WENT INTO BRADYCARDIA, PULSE 32. THE NURSING STATION MONITOR DID NOT ALARM, STAFF QUICKLY IDENTIFIED THE EVENT AND PHYSICALLY SET THE EKG ALARM/PAPER PRINT-OUT TO A MANUAL MODE. A CODE WAS CALLED AND PT RESUSCITATION WAS UNSUCCESSFUL. PRELIMINARY REVIEW OF THE EQUIPMENT BY INTERNAL BIOMEDICAL AS WELL AS THE EQUIPMENT MFR FAILED TO SHOW EQUIPMENT MALFUNCTIONS. THE MFR IS PERFORMING FURTHER TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53960 MARQUETTE CDT/CENTRAL STATION DRT GE MARQUETTE MEDICAL SYSTEMS, QA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death