BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1241913 · Received November 19, 2008

    Report

    Report Number
    2124823-2008-00090
    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
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL OF THE CIC'S IN SEVERAL CARE AREAS WERE EXPERIENCING "NO COMM" EVENTS. THE TIME ON ALL OF THE CIC'S AND BEDSIDE MONITORS IN THE HOSPITAL WOULD NOT ADVANCE PAST 7 AM. NO PT INJURY WAS REPORTED. THE REPORTED EVENT IS CAUSED BY A KNOWN CONDITION WHERE THE CIC TIME MASTER ON THE UNITY NETWORK BROADCASTS TIME CHANGES AND THE CIC REFLECTS THESE CHANGES, CAUSING 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 PT 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 2007800-067

    Patients

    Seq Age Sex Outcome Treatment
    1