BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 5576247 · Received April 14, 2016

    Report

    Report Number
    2183926-2016-00547
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    DQK
    PMA / PMN Number
    K082421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE REPORTED PROBLEM OCCURRED FROM A DEVICE MALFUNCTION BUT RATHER FROM THE USER NOT FOLLOWING INSTRUCTIONS. TROUBLESHOOTING EFFORTS REVEALED THAT THE USER HAD NOT LAUNCHED THE HEMO APPLICATION. ERROR MESSAGES AND ALERT ICONS NOTIFY THE USER THAT THERE IS A COMMUNICATION PROBLEM. OPERATORS ARE TRAINED AND PROVIDED AN OPERATORS MANUAL. THE USER MANUAL (HEMO-6373, PAGE 51) STATES, "TO START THE APPLICATION, DOUBLE-CLICK THE DESKTOP ICON OR SELECT MERGE HEMO FROM START > ALL PROGRAMS > MERGE HEALTHCARE INCORPORATED."

    Description of Event or Problem · 1

    (B)(6) MONITORS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE SYSTEM COMPRISES THE PATIENT DATA MODULE AND THE 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 HEMODYNAMICS HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN BE SHOWN AND MONITORED ON THE HEMODYNAMICS HEMO MONITOR PC. ON (B)(6) 2016, A CUSTOMER REPORTED TO (B)(6) HEALTHCARE THAT THEY EXPERIENCED PROBLEMS WITH THE HEMO MONITOR THAT DISPLAYED A RED ARROW ON THE BOTTOM OF THE HEMO MONITOR PC. THE PROBLEM OCCURRED DURING AN ACTIVE TAVR CASE WHERE THE PATIENT WAS UNDER SEDATION AND INTUBATED AND RESULTED IN A 30 MINUTE DELAY. THE HEMO MONITOR WAS REBOOTED THREE (3) SEPARATE TIMES AND RESEATED. WITH THE HEMO MONITOR DISPLAYING AN UNEXPECTED ARROW, THERE WAS A SHORT DELAY IN PATIENT DIAGNOSIS &/OR TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231879 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 10.0.1

    Patients

    Seq Age Sex Outcome Treatment
    1