BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUETTE MONITOR

    MDR report key: 287402 · Received July 13, 2000

    Report

    Report Number
    287402
    Event Type
    Injury
    Date Received
    July 13, 2000
    Date of Event
    May 27, 2000
    Report Date
    July 5, 2000
    Manufacturer
    G.E. MARQUETTE MEDICAL SYSTEMS
    Product Code
    MHX
    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 THE MONITOR PRESSURES WENT TO ZERO - NO READING MESSAGE. WHEN THEY ZEROED THE PRESSURE LINES THE VALUES CAME BACK ON THE SCREEN. THERE WAS AN "X" IN THE HEART RATE PARAMETER WINDOW AND IT WAS NOT COUNTING THE QRS'S. CUSTOMER CLAIMS THERE WAS NO AUDIBLE ALARM, HOWEVER A RED MESSAGE WAS READING "ARRHY SUSPEND" AT THE CENTRAL STATION. NO ONE WAS IN THE PT'S ROOM. ALL DATA THAT WAS STORED WAS LOST. THE PT DID NOT EXPIRE. PER HOSP RISK MGMT, BIOMEDICAL ENGINEERING WAS NOT CALLED TO CHECK MONITOR. WHEN CUSTOMER WAS ASKED IF THE ALARMS WERE WORKING, THEY STATED THAT THE ALARMS WERE FUNCTIONING, MFR'S RECORDS INDICATE THAT NEITHER GE MARQUETTE CLINICAL HELP LINE NOR SVC WERE CONTACTED CONCERNING THIS EVENT. 2. THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LAB 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 LAB TEST RESULTS. MEDWATCH REPORT INDICATED DEVICE WAS IN "ARRHY SUSPEND". FOLLOWING IS A DESCRIPTION OF ARRHYTHMIA SUSPEND (ARRHY SUSPEND) FUNCTION. A CONSISTENT DESIGN REQUIREMENT FOR THE ECG PROCESSING ALGORITHM HAS BEEN TO PROVIDE TWO DIFFERENT LEVELS OF RESPONSE TO ECG ARTIFACT DETECTION. THE FIRST LEVEL RESPONSE OCCURS IMMEDIATELY UPON DETECTION OF ARTIFACT AND RESULTS IN THE ASSERTION OF AN "ARTIFACT" ALARM. THERE IS NO ALARM TONE. THE SECOND LEVEL OF RESPONSE OCCURS WHEN THE DETECTION OF ARTIFACT LASTS FOR 20 OF THE LAST 30 SECS OF MONITORING AND RESULTS IN THE ASSERTION OF AN "ARRHY SUSPEND" ALARM. A SYSTEM WARNING (REPEATING FOGHORN TONE) IS GENERATED FROM THE MONITOR FOR THIS CONDITION, WHICH SOUNDS AT BOTH THE BEDSIDE AND AT THE CENTRAL STATION, UNTIL THE USER ACTIVELY SILENCES IT. IN BOTH CASES, THE PURPOSE OF THE ECG ARTIFACT DETECTION AND ASSOCIATED RESPONSES IS TO ADVISE THE CLINICIAN THAT ECG DATA CONDITIONS ARE POTENTIALLY COMPROMISING THE ACCURACY AND EFFECTIVENESS OF THE MONITORING EQUIPMENT. THIS CAN OCCUR FOR A NUMBER OF REASONS SUCH AS POOR ECG SIGNAL QUALITY DUE TO ELECTRODES DRYING OUT OR LEADS FAIL. BASED ON INFO PROVIDED BY THE CUSTOMER IT WAS CONCLUDED THE DEVICE OPERATED AS INTENDED. ADD'L INSTRUCTION WAS PROVIDED TO CUSTOMER EXPLAINING ARRHYTHMIA SUSPEND FUNCTION. CUSTOMER WAS SATISFIED WITH MFR'S RESPONSE. 3. PLEASE IDENTIFY AND SUBMIT MODEL NUMBER AND MFG 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 MONITORING SYSTEMS. B) SUBMIT COPIES OF ALL DESIGN CHANGES ASSOCIATED WITH FIRM'S TELEMETRY MONITORING DEVICES, BY DATE AND MODEL. CUSTOMER PROVIDED A SERIAL NUMBER FOR THE RAC 4A, WHICH IS USED IN CONJUNCTION WITH THE SOLAR MONITOR. AFTER CLARIFICATION WITH THE CUSTOMER, THE SOLAR 8000 DEVICE ANOTHER SERIAL NUMBER SHOULD HAVE BEEN REFERENCED. THIS SERIAL NUMBER INDICATES A MFG DATE OF 8/97. THE SOLAR 8000 IS A HARDWIRED BEDSIDE MONITOR, NOT A TELEMETRY-MONITORING DEVICE. A) A REVIEW OF COMPLAINT HISTORY INDICATES THERE HAVE BEEN REPORTS ASSOCIATED WITH THE ARRHYTHMIA SUSPEND FUNCTION HOWEVER INVESTIGATION OF THESE REPORTS DETERMINED THE ARRHYTHMIA SUSPEND FUNCTION TO BE OPERATING AS INTENDED. B) IN LATE 1997, AN UPDATE TO THE ECG PROCESSING ALGORITHM INCLUDED A DESIGN PROVISION, WHICH IMPACTED THE "ARRHY SUSPEND" PROCESSING. THIS NEW PROVISION ALLOWED THE "ARRHY SUSPEND" ALARM TO BE ASSERTED, IN ADDITION TO PROVISION PREVIOUSLY DESCRIBED IN QUESTION 2 (SEE #2 ABOVE), WHENEVER ECG PROCESSING ALGORITHM WAS UNABLE TO COMPUTE A NEW RATE FROM AVAILABVLE ECG DATA IN ANY 30 SECOND PERIOD. THIS DESIGN PROVISION SERVES SAME PURPOSE AS PREVIOUSLY DESCRIBED PROVISIONS FOR ECG ARTIFACT DETECTION, AND IS VIEWED AS AN ADD'L MITIGATION OF RISK THAT AN ADVERSE DATA CONDITION COULD, WITHOUT THE CLINICIAN'S KNOWLEDGE, ADVERSELY IMPACT THE PERFORMANCE OF THE EQUIPMENT. 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 7/5/00. 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. BASED ON INFO PROVIDED BY THE CUSTOMER IT WAS CONCLUDED THE DEVICE OPERATED AS INTENDED. ADD'L INSTRUCTION WAS PROVIDED TO CUSTOMER EXPLAINING THE ARRHYTHMIA SUSPEND FUNCTION. CUSTOMER WAS SATISFIED WITH MFR'S RESPONSE.

    Description of Event or Problem · 1

    MONITOR (ABP/PA/CVP) PRESSURES WENT TO ZERO; NO READING MSG). ZEROED LINES, THEN THEY CAME BACK IN SCREEN. THERE WAS AN X IN THE HR BOX BUT IT WAS NOT COUNTING THE QRS, NO AUDITORY ALARM, RED MESSAGE READING ALARM ARRHYTHMIA SUSPEND - NO ONE WAS IN ROOM, ALL DATA THAT WAS STORED WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUETTE MONITOR MONITOR-SOLAR 8000 MHX G.E. MARQUETTE MEDICAL SYSTEMS RAC 4A *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening