BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTON ECLIPSE PREMIER

    MDR report key: 1882406 · Received July 19, 2010

    Report

    Report Number
    1882406
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A CALL FROM THE (B) (6). WE SPOKE TODAY IN REFERENCE TO KEEPING AND MAINTAINING THE CORRECT TIME ON THE QUINTON/CARDIAC SCIENCE EKG CARTS LOCATED IN THE CFV AND THE EMERGENCY DEPARTMENTS (ED). THE HOSPITAL IS REQUIRED TO MAINTAIN ACCURATE TIME STAMPS ON ALL OF THE 15 EKG CARTS. THE TIME STAMP ON THESE CARTS CONTINUES TO DRIFT AND IS OFTEN OFF BY AS MUCH AS 15 MINUTES. THE EKG RECORDINGS PRINTED FROM THESE EKG CARTS NEED ACCURATE INFORMATION ON THEM. YOU CAN'T HAVE A PATIENT THAT ARRIVES AT THE ED AT 9:00 AM AND SHOW DOCUMENTATION THAT INDICATES A PROCEDURE WAS PERFORMED FIFTEEN MINUTES PRIOR TO THEM ARRIVING AT THE HOSPITAL. MOST EKG CARTS HAVE A USER FUNCTION THAT ALLOWS THE USER TO MAKE CHANGES TO THE DATE AND TIME ON THE CARTS THEMSELVES. THIS ALLOWS THE USER TO VERIFY ACCURATE INFORMATION ON A DAILY BASIS AND WOULD ALSO ALLOW THE DEPARTMENT TO BE RESPONSIBLE FOR UP KEEPING THE CORRECT TIME ON THE MACHINE. OTHER BRANDS OF EKG CARTS GAVE US THAT ABILITY. THE EKG CARTS WE NOW USE ARE MANUFACTURED BY CARDIAC SCIENCE (QUINTON). OUR EKG CARTS ONLY HAVE THE ABILITY TO CHANGE THE DATE AND TIME BY GOING INTO THE SERVICE MODE WHICH REQUIRES USING A PASSWORD. WE IN THE CLINICAL ENGINEERING DEPARTMENT HAVE ACCESS TO THIS PASSWORD ALONG WITH A COUPLE OF SELECT PEOPLE. INDIVIDUALS IN THE (B) (6) AND IN THE ED HAVE ALSO BEEN PROVIDED THIS PASSWORD. THIS PASSWORD CANNOT BE GIVEN OUT TO THE EQUIPMENT USERS BECAUSE IT WOULD ALSO GIVE THEM THE ABILITY TO MAKE OTHER CHANGES TO THE MACHINE WHICH COULD AFFECT ITS OPERATION. WE HAVE CALLED THE MANUFACTURER OF THE EKG CART AND THEY TELL US THAT THERE IS NO OTHER WAY AROUND CHANGING THE DATE AND TIME WITHOUT USING THE PASSWORD AND ENTERING THE SERVICE MODE. THE EKG CARTS TRANSFERS PATIENT DATA TO A SERVER FOR ARCHIVING, BUT THE CART DOES NOT COMMUNICATE TO THE SERVER IN ANY WAY THAT WOULD GIVE IT THE ABILITY TO SYNC TO THE CLOCK ON THE SERVER. THIS ALSO AFFECTS THE CLOCKS DURING THE TIME CHANGE TWICE A YEAR WHEN WE CHANGE THE CLOCKS BY ONE HOUR AT DAYLIGHT SAVINGS TIME. THE CLINICAL ENGINEERING DEPARTMENT HAS TO COME INTO THE FACILITY AT 2:00 AM TO MAKE THE CHANGE TO ALL OF THE EKG CARTS IN THE FACILITY. I WENT TO THE ED THIS AFTERNOON AND UPDATED ALL OF THE CLOCKS ON EACH OF THEIR EKG CARTS TO ENSURE PROPER TIME. ALL CLOCKS HAVE NOW BEEN UPDATED AS OF THIS AFTERNOON. THESE CLOCKS WERE OFF ANYWHERE FROM 2 MINUTES TO 12 MINUTES. ALTHOUGH THIS HAS NOW BEEN UPDATED AS OF THIS AFTERNOON, THIS IS STILL AN ONGOING ISSUE.BIOMEDICAL ENGINEERING HAS SPOKEN TO SEVERAL SALES REPS/MANAGERS AND A PRODUCT MANAGER REGARDING SEVERAL OTHER ISSUES. THESE ISSUES INCLUDE, BUT ARE NOT LIMITED TO: POOR MAIN BATTERY FUNCTION. THE BATTERY PACK USED ON THE CART IS MADE UP OF NI-CAD BATTERIES. THE AVERAGE LIFESPAN OF THE CURRENT BATTERY PACKS IS JUST OVER A YEAR. EVERY TIME THE BATTERIES NEED TO BE SERVICED, THE CART IS OUT OF SERVICE FOR 24 - 72 HOURS. THE MANUFACTURER STATES THAT THEY HAVE NO PLANS TO UPGRADE THE BATTERY TECHNOLOGY (TO EITHER NI-MH OR LITHIUM ION). THE SYSTEM BACKUP BATTERY IS A BUTTON CELL BATTERY. THIS BATTERY KEEPS THE SYSTEM SETTINGS AND IS NOT RECHARGEABLE. THE CART MUST BE TAKEN OUT OF SERVICE UNTIL A REPLACEMENT BATTERY CAN BE OBTAINED. WIRELESS CONNECTIVITY IS 802.11B ONLY. SIZEABLE PACKETS OF DATA REQUIRE EXTENDED TRANSMISSION PERIODS. MULTIPLE EKG CARTS OR OTHER 802.11B DEVICES TRANSMITTING AT THE SAME TIME ADVERSELY AFFECT THE ABILITY OF THE DEVICES TO COMMUNICATE. THE MANUFACTURER, AGAIN, HAS NO PLANS TO UPGRADE THE CART'S COMMUNICATION CAPABILITIES. THE WIRELESS CONNECTIVITY IS PROVIDED BY THE INSTALLATION OF AN EXTERNAL WIRELESS BRIDGE AND ANTENNAS. THIS IS POORLY DESIGNED AS THE BRIDGE, ANTENNAS AND CABLE ARE FULLY EXPOSED AND SUBJECT TO FREQUENT DAMAGE DURING NORMAL USAGE. BROKEN ANTENNAS ARE A FREQUENT OCCURRENCE AND ARE RELATIVELY COSTLY TO REPLACE. THESE CARTS ARE NOT NETWORK-TIME-PROTOCOL (NTP) CAPABLE. AND THE MANUFACTURER HAS NO PLANS TO UPGRADE THE CARTS TO PROVIDE THIS FUNCTIONALITY. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SYSTEM DOES NOT PROVIDE A MORE EFFICIENT WAY TO MAKE SURE THE CLOCK ON THE MACHINE IS ACCURATE. THEY CAN BE OFF AS MUCH AS 15 MINUTES.====================== MANUFACTURER RESPONSE FOR EKG DEVICE, QUINTON EKG======================MANUFACTURER HAS NOT PLANS TO UPGRADE THE CART'S COMMUNICATION CAPABILITIES.

    Description of Event or Problem · 1

    I RECEIVED A CALL FROM THE HEART CENTER. WE SPOKE TODAY IN REFERENCE TO KEEPING AND MAINTAINING THE CORRECT TIME ON THE QUINTON/CARDIAC SCIENCE EKG CARTS LOCATED IN THE CFV AND THE EMERGENCY DEPARTMENTS (ED). THE HOSPITAL IS REQUIRED TO MAINTAIN ACCURATE TIME STAMPS ON ALL OF THE 15 EKG CARTS. THE TIME STAMP ON THESE CARTS CONTINUES TO DRIFT AND IS OFTEN OFF BY AS MUCH AS 15 MINUTES. THE EKG RECORDINGS PRINTED FROM THESE EKG CARTS NEED ACCURATE INFORMATION ON THEM. YOU CAN'T HAVE A PATIENT THAT ARRIVES AT THE ED AT 9:00 AM AND SHOW DOCUMENTATION THAT INDICATES A PROCEDURE WAS PERFORMED FIFTEEN MINUTES PRIOR TO THEM ARRIVING AT THE HOSPITAL. MOST EKG CARTS HAVE A USER FUNCTION THAT ALLOWS THE USER TO MAKE CHANGES TO THE DATE AND TIME ON THE CARTS THEMSELVES. THIS ALLOWS THE USER TO VERIFY ACCURATE INFORMATION ON A DAILY BASIS AND WOULD ALSO ALLOW THE DEPARTMENT TO BE RESPONSIBLE FOR UP KEEPING THE CORRECT TIME ON THE MACHINE. OTHER BRANDS OF EKG CARTS GAVE US THAT ABILITY. THE EKG CARTS WE NOW USE ARE MANUFACTURED BY CARDIAC SCIENCE (QUINTON). OUR EKG CARTS ONLY HAVE THE ABILITY TO CHANGE THE DATE AND TIME BY GOING INTO THE SERVICE MODE WHICH REQUIRES USING A PASSWORD. WE IN THE CLINICAL ENGINEERING DEPARTMENT HAVE ACCESS TO THIS PASSWORD ALONG WITH A COUPLE OF SELECT PEOPLE. INDIVIDUALS IN THE HEART CENTER AND IN THE ED HAVE ALSO BEEN PROVIDED THIS PASSWORD. THIS PASSWORD CANNOT BE GIVEN OUT TO THE EQUIPMENT USERS BECAUSE IT WOULD ALSO GIVE THEM THE ABILITY TO MAKE OTHER CHANGES TO THE MACHINE WHICH COULD AFFECT ITS OPERATION. WE HAVE CALLED THE MANUFACTURER OF THE EKG CART AND THEY TELL US THAT THERE IS NO OTHER WAY AROUND CHANGING THE DATE AND TIME WITHOUT USING THE PASSWORD AND ENTERING THE SERVICE MODE. THE EKG CARTS TRANSFERS PATIENT DATA TO A SERVER FOR ARCHIVING, BUT THE CART DOES NOT COMMUNICATE TO THE SERVER IN ANY WAY THAT WOULD GIVE IT THE ABILITY TO SYNC TO THE CLOCK ON THE SERVER. THIS ALSO AFFECTS THE CLOCKS DURING THE TIME CHANGE TWICE A YEAR WHEN WE CHANGE THE CLOCKS BY ONE HOUR AT DAYLIGHT SAVINGS TIME. THE CLINICAL ENGINEERING DEPARTMENT HAS TO COME INTO THE FACILITY AT 2:00 AM TO MAKE THE CHANGE TO ALL OF THE EKG CARTS IN THE FACILITY. I WENT TO THE ED THIS AFTERNOON AND UPDATED ALL OF THE CLOCKS ON EACH OF THEIR EKG CARTS TO ENSURE PROPER TIME. ALL CLOCKS HAVE NOW BEEN UPDATED AS OF THIS AFTERNOON. THESE CLOCKS WERE OFF ANYWHERE FROM 2 MINUTES TO 12 MINUTES. ALTHOUGH THIS HAS NOW BEEN UPDATED AS OF THIS AFTERNOON, THIS IS STILL AN ONGOING ISSUE.BIOMEDICAL ENGINEERING HAS SPOKEN TO SEVERAL SALES REPS/MANAGERS AND A PRODUCT MANAGER REGARDING SEVERAL OTHER ISSUES. THESE ISSUES INCLUDE, BUT ARE NOT LIMITED TO: POOR MAIN BATTERY FUNCTION. THE BATTERY PACK USED ON THE CART IS MADE UP OF NI-CAD BATTERIES. THE AVERAGE LIFESPAN OF THE CURRENT BATTERY PACKS IS JUST OVER A YEAR. EVERY TIME THE BATTERIES NEED TO BE SERVICED, THE CART IS OUT OF SERVICE FOR 24 - 72 HOURS. THE MANUFACTURER STATES THAT THEY HAVE NO PLANS TO UPGRADE THE BATTERY TECHNOLOGY (TO EITHER NI-MH OR LITHIUM ION). THE SYSTEM BACKUP BATTERY IS A BUTTON CELL BATTERY. THIS BATTERY KEEPS THE SYSTEM SETTINGS AND IS NOT RECHARGEABLE. THE CART MUST BE TAKEN OUT OF SERVICE UNTIL A REPLACEMENT BATTERY CAN BE OBTAINED. WIRELESS CONNECTIVITY IS 802.11B ONLY. SIZEABLE PACKETS OF DATA REQUIRE EXTENDED TRANSMISSION PERIODS. MULTIPLE EKG CARTS OR OTHER 802.11B DEVICES TRANSMITTING AT THE SAME TIME ADVERSELY AFFECT THE ABILITY OF THE DEVICES TO COMMUNICATE. THE MANUFACTURER, AGAIN, HAS NO PLANS TO UPGRADE THE CART'S COMMUNICATION CAPABILITIES. THE WIRELESS CONNECTIVITY IS PROVIDED BY THE INSTALLATION OF AN EXTERNAL WIRELESS BRIDGE AND ANTENNAS. THIS IS POORLY DESIGNED AS THE BRIDGE, ANTENNAS AND CABLE ARE FULLY EXPOSED AND SUBJECT TO FREQUENT DAMAGE DURING NORMAL USAGE. BROKEN ANTENNAS ARE A FREQUENT OCCURRENCE AND ARE RELATIVELY COSTLY TO REPLACE. THESE CARTS ARE NOT NETWORK-TIME-PROTOCOL (NTP) CAPABLE. AND THE MANUFACTURER HAS NO PLANS TO UPGRADE THE CARTS TO PROVIDE THIS FUNCTIONALITY. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SYSTEM DOES NOT PROVIDE A MORE EFFICIENT WAY TO MAKE SURE THE CLOCK ON THE MACHINE IS ACCURATE. THEY CAN BE OFF AS MUCH AS 15 MINUTES.====================== MANUFACTURER RESPONSE FOR EKG DEVICE, QUINTON EKG======================MANUFACTURER HAS NOT PLANS TO UPGRADE THE CART'S COMMUNICATION CAPABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON ECLIPSE PREMIER ELECTROCARDIOGRAPH DPS CARDIAC SCIENCE CORPORATION QUINTON ECLIPSE PREMIER *

    Patients

    Seq Age Sex Outcome Treatment
    1 *