BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 6405043 · Received March 14, 2017

    Report

    Report Number
    2183926-2017-00063
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 15, 2017
    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
    MO, 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 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. REVISED INFORMATION CONTAINED IN THIS SUPPLEMENTAL REPORT INCLUDES THE FOLLOWING: H6 - EVALUATION CODES: 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]. H10 - INDICATION OF ADDITIONAL MANUFACTURER INFORMATION IS CONTAINED IN THIS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED PROBLEM IS CURRENTLY UNDER INVESTIGATION BY MERGE HEALTHCARE (HEMO-5599). FOR THIS REASON, (B)(4) WAS USED. WHEN MORE INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 FEBRUARY 15, 2017, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE HEMO MONITOR FROZE DURING A PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS MOVED TO ANOTHER LAB. THIS RESULTED IN A LOSS OF PATIENT MONITORING. WITH MERGE HEMO NOT CAPTURING PHYSIOLOGICAL DATA, THERE IS A POTENTIAL FOR DELAY IN TREATMENT THAT COULD RESULT IN HARM TO THE PATIENT. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE THE PATIENT WAS MOVED TO ANOTHER FUNCTIONING LAB. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185035 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 9.40.3

    Patients

    Seq Age Sex Outcome Treatment
    1