BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2103382 · Received May 17, 2011

    Report

    Report Number
    2124823-2011-00071
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NETWORK WENT DOWN RESULTING IN A LOSS OF PT MONITORING AFFECTING UP TO 40 TELEMETRY PTS AND UP TO 40 BEDSIDE PTS FOR APPROX 2 HOURS. BACKUP MONITORING WAS NOT AVAILABLE FOR ALL TELEMETRY PTS. THERE WAS NO SERIOUS INJURY, DEATH, OR INTERVENTION REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL STATION DXJ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1