BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 1873594 · Received September 17, 2010

    Report

    Report Number
    2124823-2010-00097
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    July 11, 2010
    Report Date
    September 17, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED AT THIS TIME, WITHOUT THE SERIAL NUMBER OF THE DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A LOSS OF TELEMETRY MONITORING OCCURRED WHEN FOUR (4) CIC (CENTRAL STATIONS) REBOOTED SIMULTANEOUSLY. NO INJURY WAS REPORTED. THIS IS THE SECOND OF FOUR REPORTS. 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 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1