BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 1885088 · Received October 20, 2010

    Report

    Report Number
    2124823-2010-00110
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 20, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED THAT A NURSE IS FRONT OF THE CIC (CENTRAL STATION) DISPLAY WITNESSED AN ASYSTOLE EVENT, AND ALLEGES THE CIC DID NOT PROVIDE AN AUDIBLE ALARM. THE PATIENT WAS SUCCESSFULLY TREATED WITH CARDIAC MASSAGE. 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 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MOITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1