BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2180843 · Received July 21, 2011

    Report

    Report Number
    2124823-2011-00111
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CIC PRO CLINICAL INFORMATION CENTER (CIC) FAILED TO PRODUCE AN AUDIBLE ALARM FOR A PT EXPERIENCING BRADYCARDIA FOLLOWED BY ASYSTOLE. THE PT WAS DISCOVERED TO BE CYANOTIC AND UNRESPONSIVE AND A CODE WAS CALLED AT 19:43 ON (B)(6) 2011. THE PT WAS REVIVED AND PLACED ON A VENTILATOR BUT LATER EXPIRED AT 20:06. THE SITE REPORTS THAT THE BEDSIDE MONITOR ALARMED AS EXPECTED, BUT THERE WAS NO AUDIBLE ALARM CAPABILITY AT THE CIC STATION. THE SITE'S BIOMEDICAL ENGINEER WAS CALLED IN TO CHECK THE EQUIPMENT AND COULD NOT GET THE CIC TO AUDIBLY ALARM. HE CHANGED OUT THE SPEAKERS AND THE SYSTEM STILL COULD NOT AUDIBLY ALARM. THE BIOMEDICAL ENGINEER REBOOTED THE CIC AND THE SYSTEM THEN STARTED AUDIBLY ALARMING AS EXPECTED. 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 Death