BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 8353535 · Received February 20, 2019

    Report

    Report Number
    2183926-2016-00644
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    June 10, 2016
    Report Date
    June 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MERGE HEALTHCARE CONDUCTED AN INTERNAL QUALITY INVESTIGATION TO ADDRESS THE ISSUE REPORTED IN RECALL (B)(4), FDA RECALL NUMBER (B)(4). 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 0630IN 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.

    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 THE HEMO MONITOR STOPPED WORKING AFTER A PATIENT WAS SEDATED AND CONNECTED TO ACTIVE MONITORING. THE CUSTOMER STATED THERE WAS "A SLIGHT DELAY" WHILE THE HEMO MONITOR WAS REBOOTED AND THEN NO FURTHER ISSUES WERE ENCOUNTERED. WITH MERGE HEMO NOT PRESENTING PHYSIOLOGICAL DATA DURING TREATMENT, THERE IS A POTENTIAL FOR A DELAY IN CARE THAT RESULTS IN HARM TO THE PATIENT. HOWEVER, THE CUSTOMER STATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE THE HEMO MONITOR WAS MANUALLY REBOOTED. REFERENCE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149192 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 9.40

    Patients

    Seq Age Sex Outcome Treatment
    1