BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2122027 · Received May 24, 2011

    Report

    Report Number
    2124823-2011-00080
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 24, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A GE HEALTHCARE BIOMEDICAL ENGINEER THAT A CIC PRO SYSTEM WOULD DISPLAY VISUAL WARNING ALARMS AND MESSAGES BUT WOULD NOT PRODUCE AN AUDIBLE ALARM. THE SPECIFIC TYPE OF ALARM WAS NOT REPORTED. THE SYSTEM WAS MONITORING 12 PATIENTS. THERE WERE NO REPORTED PATIENT INCIDENTS, INJURIES, OR DELAYS IN TREATMENT DURING THIS EVENT. THE SYSTEM SPEAKERS WERE CHECKED AND REPLACED WITHOUT ANY CHANGE IN THE SITUATION. THE ALARM VOLUME LEVEL WAS SET AT 60%. THE SYSTEM WAS REBOOTED USING THE SAFE-SHUTDOWN PROCEDURE AND THE ISSUE WAS REPORTED TO BE RESOLVED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED 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