BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFO CENTER

    MDR report key: 1023575 · Received April 2, 2008

    Report

    Report Number
    2124823-2008-00043
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 9, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K053356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "TIMESTORM" ON THE NETWORK ALLEGEDLY DISRUPTED PT MONITORING FOR AN EXTENDED PERIOD OF TIME. ADDITIONAL HOSPITAL STAFF WERE REQUIRED TO PROVIDE CLOSE PERSONAL SURVEILLANCE OF THE PTS. NO DEATH OR SERIOUS INJURY OCCURRED. 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 CLINICAL INFO CENTER UNITY NETWORK DSI GE HEALTHCARE 2019989-003

    Patients

    Seq Age Sex Outcome Treatment
    1