BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1023574 · Received April 2, 2008

    Report

    Report Number
    2124823-2008-00044
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 22, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K053356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TIMESTORM ON THE NETWORK DISRUPTED PT MONITORING FOR AN EXTENDED PERIOD OF TIME. CIC'S HAD TO BE MANUALLY REBOOTED. NO 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 UNITY NETWORK DXJ GE HEALTHCARE 2019989-003

    Patients

    Seq Age Sex Outcome Treatment
    1