BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1241915 · Received November 19, 2008

    Report

    Report Number
    2124823-2008-00093
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIME WOULD NOT ADVANCE PAST 02:00 ON THE CIC. THE USERS NOTED PT WAVEFORMS WERE DROPPING OUT ON THE CIC FOR BOTH HARDWIRE AND TELEMETRY MONITORING. THE WAVEFORMS WOULD ALLEGEDLY DISAPPEAR FOR APPROXIMATELY ONE MINUTE, AND THEN WOULD REAPPEAR. THE REPORTED EVENT RESEMBLES 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. NO PT 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 INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE 2019989-003

    Patients

    Seq Age Sex Outcome Treatment
    1