BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE 4000

    MDR report key: 1111608 · Received August 13, 2008

    Report

    Report Number
    2124823-2008-00068
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 13, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    LOS
    PMA / PMN Number
    K964750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THEIR EAGLE MONITOR FAILED TO ALARM FOR ASYSTOLE. NO PATIENT DEATH OR INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE 4000 PATIENT MONTIOR LOS GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1