BEUDAMED
    FDA Adverse Event Death Summary report: N

    G.E. MARQUETTE MONITOR

    MDR report key: 287396 · Received July 13, 2000

    Report

    Report Number
    287396
    Event Type
    Death
    Date Received
    July 13, 2000
    Date of Event
    April 24, 2000
    Report Date
    July 5, 2000
    Manufacturer
    G.E. MARQUETTE MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/15/00: 1. A MORE COMPLETE DESCRIPTION OF THE INCIDENT DESCRIBED IN THE ADVERSE EVENT REPORT INCLUDING RELEVANT EVENT PRIOR TO AND SUBSEQUENT TO THE ACTUAL INCIDENT. INFO OBTAINED FROM THE CUSTOMER IS AS FOLLOWS: CUSTOMER CLAIMS PT IN ICU12 WENT INTO ASYSTOLE AND THE MONITOR DID NOT ALARM AT THE BEDSIDE OR CENTRAL STATION. A CODE WAS CALLED AT 07:22 LOCAL TIME. THE PT EXPIRED. 2. THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORTS INCLUDING: A) A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED, B) AN IDENTIFICATION OF THE FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED COMPONENT(S) INVOLVED, C) ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. INVESTIGATION CONSISTED OF REVIEW OF EVENT LOGS RECOVERED FROM THE DEVICE. LOGS INDICATED MONITOR ALARMED APPROPRIATELY AND DEVICE OPERATED AS INTENDED. NO USER ERROR WAS FOUND IN REGARD TO EQUIPMENT OPERATION. ADD'L INSTRUCTION WAS PROVIDED TO CUSTOMER EXPLAINING MONITOR FUNCTION. CUSTOMER WAS SATISFIED WITH RESPONSE. 3. PLEASE IDENTIFY AND SUBMIT MODEL NUMBER AND MFR DATE OF PRODUCT ASSOCIATED WITH THE ADVERSE EVENT ASSOCIATED WITH THIS REQUEST IN ADDITION, PLEASE ADDRESS THE FOLLOWING: A) INDICATE IF RPTR HAS RECEIVED ANY COMPLAINTS/NOTIFICATIONS OF FAILURES ASSOCIATED WITH THE SAME MODEL AS THOSE REPORTED OR ANY OTHER MODELS OF RPTR'S MONITORING SYSTEMS. B) SUBMIT COPIES OF ALL DESIGN CHANGES ASSOCIATED WITH FIRM'S TELEMETRY MONITORING DEVICES, BY DATE AND MODEL. SOLAR 8000 PHYSIOLOGIC PT MONITOR, MFG IN 8/97, IS A HARDWIRED BEDSIDE MONITOR, NOT A TELEMETRY MONITORING DEVICE. A) MONITOR OPERATED AS INTENDED (#2 ABOVE). B) MONITOR OPERATED AS INTENDED (#2 ABOVE). 4. PLEASE PROVIDE THE DATE FIRM RECEIVED INFO ABOUT THE EVENTS DESCRIBED IN THE ATTACHED ADVERSE EVENT REPORTS. GE MARQUETTE MEDICAL SYSTEMS WAS INFORMED ON 4/24/00. 5. PLEASE PROVIDE COPIES OF ALL VERSIONS OF PRODUCT LABELING/PACKAGING, AND TECHNICAL/USER MATERIALS FOR EACH OF FIRM'S TELEMETRY MONITORS, BY DATE AND MODEL, INCLUDING DIRECTIONS FOR USE, CAUTION STATEMENTS, AND TECHNICAL MANUALS. THE SOLAR 8000 IS A HARDWIRED BEDSIDE MONITOR, NOT A TELEMETRY-MONITORING DEVICE. ENCLOSED WITH THIS RESPONSE, PLEASE FIND COPIES OF THE OPERATOR AND SVC MANUALS FOR THE SOLAR 8000 PHYSIOLOGIC PT MONITOR. 6. PLEASE SUBMIT COPIES BY DATE AND MODEL, OF ALL TECHNICAL MEMORANDUMS, USER NOTIFICATIONS AND PRODUCT UPDATES ISSUED BY FIRM ASSOCIATED WITH TELEMETRY MONITOR DEVICES. THE SOLAR 8000 IS A HARDWIRED BEDSIDE MONITOR, NOT A TELEMETRY-MONITORING DEVICE. THERE HAVE BEEN NO TECHNICAL MEMORANDUMS, OR USER NOTIFICATIONS, OR UPDATES REGARDING THE ARRHYTHMIA SUSPEND FUNCTION. 7. PLEASE PROVIDE A COPY OF FIRM'S EVALUATION AND ANY ACTION TAKEN TO ADDRESS THE PROBLEMS REFERENCED IN THE ATTACHED REPORT. LOG FILES COPIED FROM THE MONITOR IN QUESTION WERE ANALYZED AND THE FOLLOWING WAS DETERMINED. THE CENTRAL STATION ERROR LOG INDICATES ALARMS WERE PAUSED AT 06:47 AND REACTIVATED AT 06:52. NO ALARMS WERE CALLED PRIOR TO 06:47. AT 07:05 A HR (HEART RATE) LOW LIMIT VIOLATION WAS CALLED. THIS EVENT WAS GRAPHED. FROM 07:05 TO 07:11 THE PT REMAINED IN A HR LOW LIMIT VIOLATION STATE. AT 07:11 ARRHYTHMIA PROCESSING (ARR SUSPEND) WAS SUSPENDED UNTIL 07:22. AT 07:22, THE MONITOR ALARMED AGAIN FOR A HR LOW LIMIT VIOLATION. AT 07:25 THE MONITOR ALARMED FOR HR LOW LIMIT VIOLATION (HR 10). THESE EVENTS WERE GRAPHED. AT 07:25:38 A CRISIS ASYSTOLE ALARM WAS CALLED. THIS ALARM WAS SILENCED FROM THE CENTRAL STATION. THE PT REMAINED IN ASYSTOLE AND VFIB/VTACH ALARMING UNTIL 10:17. ALARMS WERE BEING SILENCED DURING THIS PERIOD AND EVENTS BEING GRAPHED. DATA FOR ICU12 ENDED AT 13:24. IT WAS DETERMINED THAT THE SYSTEM RESPONDED APPROPRIATELY. INVESTIGATION DETERMINED IT WAS NOT CAUSAL IN THE PT OUTCOME. ADD'L INSTRUCTION WAS PROVIDED TO CUSTOMER EXPLAINING MONITOR FUNCTION. CUSTOMER WAS SATISFIED WITH RESPONSE.

    Description of Event or Problem · 1

    PT WENT INTO ASYSTOLE WITHOUT MONITOR ALARMING AT THE CENTRAL STATION. CODE WAS CALLED - PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E. MARQUETTE MONITOR SOLAR 8000 MHX G.E. MARQUETTE MEDICAL SYSTEMS SOLAR 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death