BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000

    MDR report key: 442250 · Received February 5, 2003

    Report

    Report Number
    442250
    Event Type
    Malfunction
    Date Received
    February 5, 2003
    Date of Event
    August 30, 2002
    Report Date
    September 10, 2002
    Manufacturer
    GE MEDICAL INFORMATION SYSTEMS
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TITLE: G.E. MARQUETTE ECG DROP-OUT. THE ECG [ELECTROCARDIOGRAM] WAVEFORM BLANKS OUT [DISAPPEARS] DURING MONITORING IN THE PT ROOM. [THESE UNITS ARE BEDSIDE UNITS THAT ARE SIMULTANEOUSLY BEING MONITORED BY A CENTRAL STATION WHICH DISPLAYS THE SAME PROBLEM.] THIS [MALFUNCTION] CAUSES ANXIETY WITH THE DOCTORS AND NURSES WHEN PERFORMING A PROCEDURE. ECG RESUMES WITHIN 3-5 SECONDS. THE MONITOR CONTINUES TO STORE PT DATA. [WHEN THE WAVEFORMS DISAPPEAR THE NUMERICAL VALUES SUCH AS HEART RATE AND THE OXYGEN SATURATION ARE FROZEN ON THE LAST RECORDED VALUE. WHEN LOOKING BACK IN THE MACHINE HISTORY, THERE DOES NOT APPEAR TO BE ANY MISSING DATA.] GE MARQUETTE HAS BEEN NOTIFIED ABOUT THIS PROBLEM AND DOES NOT OFFER A REMEDY. THE ENTIRE SYSTEM HAS BEEN CHANGED OUT INCLUDING ALL NETWORK CABLING IN TWO ROOMS AND ALL COMPONENTS OF THE BEDSIDE UNIT. [THE BEDSIDE UNIT INCLUDES THE MONITOR THE TRAM RAC, AND THE TRAM MODULE [WHICH ARE PART OF THE COMMUNCATION PROCESSOR UNIT,] THE SOLAR 8000, AND ALL OF THE CABLING. THE MFR WAS NOT INVOLVED IN MAKING ANY OF THE CHANGES.] THIS PROBLEM CONTINUES TO BE AN IRRITANT TO THE HEALTH CARE PROVIDERS BECAUSE THIS CAN CAUSE AN ADVERSE SITUATION IF THE MONITORING UNIT WAS TO DROP OUT [MALFUNCTION] DURING A CRITICAL PROCEDURE. [THE PROBLEM HAS BEEN REPLICATED USING A TEST SIGNAL RATHER THAN A PT. THE WAVEFORMS DISAPPEAR UNDER ALL CONDITIONS AND TIMES, INCLUDING WHEN THE ROOM HAS OTHER PERSONNEL IN IT AS WELL AS WHEN A PT IS ALONE AND SLEEPING.] THE DROP OUT OCCURS WITH ANY AND ALL WAVEFORMS THAT ARE ON THE SCREEN AND WITH MORE THAN ONE MONITOR. THERE HAVE BEEN NO PT INJURIES AS A DIRECT RESULT OF THIS DEVICE MALFUNCTION. THE SYSTEM WAS INSTALLED FIVE YEARS AGO. IN THE BEGINNING, ONE ROOM EVIDENCED THE PROBLEM. OVER THE PAST FIVE YEARS OTHER ROOMS HAVE DISPLAYED THE PROBLEM. THE PROBLEM CAN OCCUR ONCE EVERY TWO MONTHS TO AS OFTEN AS THREE TIMES PER WEEK. THERE ARE ROUTINE MAINTENANCE CHECKS PERFORMED ON THE DEVICES EVERY 6 MONTHS. THESE DEVICES ARE USED IN THE CORONARY AND INTENSIVE CARE UNITS AT THIS FACILITY. IT IS NOT KNOWN IF THIS MALFUNCTION HAS MORE TO DO WITH THE SOFTWARE THAN THE MONITOR ITSELF. THERE IS NO EVIDENCE TO SUGGEST OTHER EQUIPMENT WAS INTERFERING WITH THIS DEVICE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/2/04: THE MODEL NUMBER IS SOLAR 8000. THE BRAND NAME IS SOLAR 8000 PT MONITORING SYSTEM. THE TYPE OF DEVICE IS A PHYSIOLOGIC PT MONITOR. THE USER FACILITY WAS UNABLE PROVIDE THE SERIAL NUMBER OF THE DEVICE. THE USER FACILITY REPORTED THE SOLAR 8000 PERIODICALLY EXPERIENCED LOOS OF DISPLAY OF ECG WAVEFORMS. THE BIOMEDICAL ENGINEER AT THE USER FACILITY RESOLVED THIS ISSUE THROUGH NORMAL REPAIR AND MAINTENANCE OF THE EQUIPMENT. THE BIOMEDICAL ENGINEER AT THE USER FACILITY RESOLVED THIS ISSUE THROUGH NORMAL REPAIR AND MAINTENANCE OF THE EQUIPMENT. THE BIOMEDICAL ENGINEER AT THE USER FACILITY DETERMINED THE EVENTS DESCRIBED WERE ATTRIBUTABLE TO THE DEVICE. GE MEDICAL SYSTEMS INFO TECHNOLOGIES DID NOT RECEIVE A COMPLAINT FOR THIS ISSUE FROM THE USER FACILITY. MFR RECEIVED THE INFO FROM THE FDA REGARDING THIS ISSUE IN THE LETTER DATED APRIL 22, 2003. MFR REVIEWED ITS COMPLAINT SYSTEM AND FOUND NO DOCUMENTED COMPLAINTS FOR THIS ISSUE FROM HOSPITAL. MFR REVIEWED ITS TECHNICAL APPLICATION HELP LINE AND DID NOT FIND ANY CALLS DOCUMENTED FOR THIS ISSUE FROM HOSPITAL. MFR REVIEWED ITS SERVICE HISTORY RECORDS AND FOUNF ROUTINE REQUESTS FOR SERVICE RELATED TO "DROP OUT", BUT ALL REQUESTS FOR SERVICE WERE RESOLVED. MFR CONTACTED THE USER FACILITY TO RECEIVE THE INFO RELATED TO THIS ISSUE. NO PERSON DIED OR WAS INJURED AS A RESULT OF THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT. THE DEVICE REMAINS IN USE AT THE USER FACILITY. THE BIOMEDICAL ENGINEER, AT THE USER FACILITY, INDICATED THE ISSUE WAS RESOLVED AND THEY HAVE HAD NO FURTHER INSTANCES OF THIS ISSUE AT THEIR FACILITY. THE DEVICE IS A SOLAR 8000 PT MONITORING SYSTEM AND IS INTENDED TO MONITOR PHYSIOLOGIC PARAMETER DATA ON ADULT, PEDIATRIC AND NEONATAL PTS WITHIN A HOSPITAL OR FACILITY PROVIDING PT CARE. GEMS-IT DID NOT CONDUCT AN INVESTIGATION. THE INVESTIGATION AND RESOLUTION WAS DONE AT THE USER FACILITY. THE BIOMEDICAL ENGINEER AT THE USER FACILITY RESOLVED THE ISSUE THROUGH NORMAL REPAIR AND MAINTENANCE OF THE EQUIPMENT. GEMS-IT REVIEWED CURRENT PRODUCT LABELING FOR THE DEVICE. AS INDICATED IN THE SOLAR 7000/8000 PT MONITOR OPERATOR'S MANUAL (PN 2000711-006) THERE ARE CAUTIONS FOR SAFE USE OF THE DEVICE. THE CAUTION STATES: "SHOULD THE MONITOR AT ANY TIME TEMPORARILY LOSE PT DATA, THE POTENTIAL EXITS THAT ACTIVE MONITORING IS NOT BEING ODNE. CLOSE PT OBSERVATION OR ALTERNATE MONITORING DEVICES SHOULD BE USED UNTIL MONITOR FUCNTION IS RESTORED. IF THE MONITOR DOES NOT AUTOMATICALLY RESUME OPERATION WITHIN 60 SECONDS, POWER CYCLE THE MONITOR USING THE POWER ON/OFF SWITCH. ONCE MONITORING IS RESTORED, YOU SHOULD VERIFY CORRECT MONITORING STATE AND ALARM FUNCTION." THE CONCLUSION CODE IS BASED ON THE INVESTIGATION CONDUCTED BY THE USER FACILITY'S BIOMEDICAL ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 8000 [MODULAR] PATIENT MONITOR DRT GE MEDICAL INFORMATION SYSTEMS SOLAR 8000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA