BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1242864 · Received November 19, 2008

    Report

    Report Number
    2124823-2008-00085
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE WAS EXPERIENCING TELEMETRY DROP OUT, INABILITY TO PRINT, AND THE INCORRECT ITEM STAMP ON THE MONITORS. BEDSIDE MONITORS ALLEGEDLY NEEDED TO BE DISCONNECTED FROM THE NETWORK. INJURY WAS REPORTED. ENGINEERING LOG FILE ANALYSIS REVEALED THAT THE USER FACILITY EXPERIENCED A CONDITION WHERE THE TIME MASTER (ONE CIC) ON THE UNITY 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. 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 INFORMATION CENTER CENTRAL MONITORING SYSTEM MHX GE HEALTHCARE 2019989-002

    Patients

    Seq Age Sex Outcome Treatment
    1