BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 6095057 · Received November 11, 2016

    Report

    Report Number
    2183926-2016-00791
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    DQK
    PMA / PMN Number
    K082421
    Removal / Correction Number
    Z-0665-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MERGE HEALTHCARE CONDUCTED AN INTERNAL QUALITY INVESTIGATION TO ADDRESS THE ISSUE REPORTED IN RECALL 2183926-02/15/2016-031-C, FDA RECALL NUMBER Z-0665-2017. MERGE HEALTHCARE RECEIVED REPORTS OF THE HEMO MONITOR APPLICATION UNEXPECTEDLY STOPPING TO DISPLAY AND UPDATE PATIENT DATA. WHEN THIS ISSUE OCCURS, THE HEMODYNAMICS SYSTEM IS NO LONGER CAPTURING PATIENT DATA. FOR CUSTOMERS WHO EXPERIENCE THIS ISSUE, IT IS RECOMMENDED THAT THE HEMO MONITOR PC IS POWER CYCLED. ONCE THE SYSTEM IS POWERED UP, THE HEMO APPLICATION SHOULD RESTART WITH NORMAL FUNCTIONALITY AND WILL ONCE AGAIN DISPLAY, UPDATE AND RECORD PATIENT DATA. THE RESTARTING OF THE HEMO MONITOR PC MAY RESULT 0630 IN A DELAY OF UP TO TWO MINUTES WHILE THE SYSTEM REBOOTS. THE INVESTIGATION AND TROUBLESHOOTING ACTIVITIES CONDUCTED BY MERGE HEALTHCARE FOUND THAT THE ISSUE OCCURRED DUE TO AN ERROR WHEN INTERFACING WITH A SPECIFIC LOCATION WITHIN A SCHILLER PDM (PATIENT DATA MODULE) FILE. MERGE HAS VALIDATED AND RELEASED A FIRMWARE FIX FOR THIS ISSUE. THIS FIX IS INCORPORATED INTO THE SOFTWARE UPGRADE OF MERGE HEMO 9.40.3 PATCH 1 (OR LATER), OR MERGE HEMO 10.0.3 PATCH 1 (OR LATER). THE CORRECTION HAS BEEN VERIFIED TO BE EFFECTIVE AS IS EVIDENCED THROUGH THE LARGE REDUCTION OF CUSTOMER COMPLAINTS CONCERNING THIS ISSUE. METHODS: 22 - SOFTWARE EVALUATION. RESULTS: 110 - DESIGN ERROR [THE DEVICE OR COMPONENT HAD FAULTY (INCOMPLETE OR INCORRECT) SOFTWARE DESIGN]. CONCLUSIONS CODE: 12 - DESIGN DEFICIENCY [THE DEVICE PROBLEM WAS TRACED BACK TO THE DESIGN SPECIFICATIONS (E.G. IN THE REQUIREMENTS, TESTING PROCESSES, HAZARD ANALYSIS, IMPLEMENTATION STRATEGY].

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED PROBLEM IS CURRENTLY UNDER INVESTIGATION BY MERGE HEALTHCARE. FOR THIS REASON, (B)(4) (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) WAS USED. WHEN MORE INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. HARDWARE NOT YET RETURNED.

    Description of Event or Problem · 1

    MERGE HEMODYNAMICS MONITORS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE MERGE HEMODYNAMICS HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS AND EVALUATIONS ARE REGISTERED AND CALCULATED IN THE PATIENT DATA MODULE. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE MERGE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2016, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT PROBLEMS WERE EXPERIENCED WITH THE HEMO MONITOR IN THE BEGINNING OF A PROCEDURE RESULTING IN THE HEMO MONITOR BEING REBOOTED. ONCE THE REBOOT WAS COMPLETE, AN ERROR MESSAGE WAS DISPLAYED THAT PREVENTED THE PATIENT'S VITALS FROM BEING MONITORED. AN EXTERNAL MONITORING DEVICE WAS USED AND MANUAL CHARTING WAS COMPLETED. THE CUSTOMER DID NOT REPORT THE PROBLEM TO MERGE HEALTHCARE WHEN IT OCCURRED BUT RATHER DISCLOSED THE OCCURRENCE ON (B)(6) 2016 WHEN INFORMATION WAS OBTAINED FOR ANOTHER REPORTED PROBLEM. THE CUSTOMER DID NOT KNOW THE EXACT DATE THE PROBLEM OCCURRED BUT STATED THAT "IT HAPPENED ABOUT 2 WEEKS AGO." THE DATE OF (B)(6) 2016 HAS BEEN USED BASED ON THE APPROXIMATE TIMEFRAME. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR DELAY IN TREATMENT THAT COULD CAUSE HARM TO THE PATIENT. HOWEVER, THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING EXTERNAL MONITORING. REFERENCE COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747030 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 10.0

    Patients

    Seq Age Sex Outcome Treatment
    1