BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFO CENTER

    MDR report key: 1241909 · Received November 19, 2008

    Report

    Report Number
    2124823-2008-00087
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE HEATHCARE
    Product Code
    MHX
    PMA / PMN Number
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FACILITY EXPERIENCED A CONDITION WHERE THE TIME MASTER (ONE CIC) ON THE UTILITY NETWORK BROADCASTS TIME CHANGES AND THE OTHER NETWORKED CICS REFLECT THESE CHANGES, RESULTING IN MULTIPLE TIME REQUESTS AND EXCESSIVE NETWORK TRAFFIC. THE CONDITION CAN LEAD TO A LOSS OF MONITORING ON THE UNITY NETWORK, WHICH MAY DELAY RECOGNITION AND TREATMENT OF A CRITICAL PATIENT EVENT. NO PATIENT 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 CLINICAL INFO CENTER CENTRAL MONITORING SYSTEM MHX GE HEATHCARE 2019989-002

    Patients

    Seq Age Sex Outcome Treatment
    1