BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1620153 · Received February 25, 2010

    Report

    Report Number
    2124823-2010-00012
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 25, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K001112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE EXAMINED THE CIC (CENTRAL STATION) LOG FILES FROM THE REPORTED EVENT. THE LOGS CONFIRMED THAT A CLINICAL EVENT WAS RECOGNIZED AT 13:54:48 AND WAS ANNOUNCED, VISUALLY AND AUDIBLY AS A VFIB/VTAC (VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA) EVENT. THIS WAS SOUNDED AT A CRITICAL PRIORITY AND AT 70% OF THE MAXIMUM VOLUME OF THE CIC. AT APPROXIMATELY 13:55:02, THE SYSTEM ANNOUNCED (VISUALLY AND AUDIBLY) AND ASYSTOLE EVENT WAS OCCURRING. AN OPERATOR AT THE CIC SILENCED THE ALARMING AT 13:55:02. A SECOND EVENT OCCURRED AT 13:55:24 FOR THE SAME TELEMETRY PATIENT WHERE A VFIB/VTAC WAS ANNOUNCED VISUALLY AND AUDIBLY AT A CRITICAL PRIORITY AND AT 70% OF THE MAXIMUM VOLUME OF THE CIC. THE SYSTEM THEN ANNOUNCED AT 13:55:28 THAT THE TELEMETRY PATIENT WAS HAVING AN ASYSTOLE EVENT. AN OPERATOR AT THE CIC SILENCED ALARMING SEVERAL TIMES STARTING AT 13:55:30. AT APPROXIMATELY 13:55:36, AN OPERATOR AT THE CIC SELECTED THE ALARM HISTORY FOR THE TELEMETRY PATIENT IN QUESTION AND PROCEEDED TO DELETE THE 4 EVENTS. BASED ON THE INFORMATION PROVIDED IN THE LOG FILES, THE SYSTEM OPERATED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT INTO VTACH/VFIB AT 13:54PM. AT 13:55PM, THE PATIENT LOST THE QRS, AND AT 2:10PM, THE NURSE CALLED ASKING FOR THE STATUS OF THE PATIENT FROM THE TELEMETRY TECHNICIAN. THE TECHNICIAN NOTED THE PATIENT WAS ASYSTOLE AND PACER SPIKES WERE BEING DISPLAYED. THE CUSTOMER STATES THAT THERE WAS NO AUDIBLE ALARM PROVIDED. THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DXJ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death