BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE 4000

    MDR report key: 1024147 · Received March 20, 2008

    Report

    Report Number
    2124823-2008-00040
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    November 13, 2007
    Report Date
    March 20, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K964750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 32 EAGLE MONITORS SHUT DOWN FROM 12:00 TO 16:30. NO PT 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 PT MONITOR MHX GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *