BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUETTE EAGLE 4000

    MDR report key: 1061638 · Received June 10, 2008

    Report

    Report Number
    1061638
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    April 25, 2008
    Report Date
    June 10, 2008
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE LOOKED AT MONITOR, AND NOTED INFANT WAS BRADYCARDIC WITH A HEART RATE OF 57, SP02 70'S; BUT THE MONITOR WAS NOT ALARMING. NURSE CHECKED AND ALL THE ALARMS WERE SET APPROPRIATELY, AND THE ALARM VOLUME WAS AT 100%. DEVICE REMOVED FROM SERVICE AND SENT TO BIOMEDICAL SERVICES. NO UNTOWARD PATIENT HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE EAGLE 4000 MONITOR, PHYSIOLOGIC MHX GE MEDICAL SYSTEMS A0EJ3547N *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO