BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 1882673 · Received October 13, 2010

    Report

    Report Number
    2124823-2010-00107
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTS A LOSS OF TELEMETRY MONITORING WHEN THE CIC (CENTRAL STATION) REBOOTS. NO INJURY HAS BEEN REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U 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