BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMODYNAMICS

    MDR report key: 5731368 · Received June 16, 2016

    Report

    Report Number
    2183926-2016-00602
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 17, 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 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: UPDATED CONTACT OFFICE - NAME/ADDRESS. DATE NEW INFORMATION RECEIVED BY MANUFACTURER (PLANNED IMPLEMENTATION DATE). INDICATION THAT THIS IS FOLLOW-UP REPORT 1. INDICATION OF MALFUNCTION AS REPORTABLE EVENT. INDICATION OF ADDITIONAL INFORMATION AND DEVICE EVALUATION. INDICATION THAT DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODES: (B)(4). ADDITION OF FDA ASSIGNED RECALL REPORTING NUMBER. 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-8363). FOR THIS REASON, CONCLUSIONS CODE (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) 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 (B)(6) 2016, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT THE HEMO MONITOR FROZE AND NEEDED TO BE REBOOTED. INFORMATION OBTAINED FROM THE CUSTOMER CONFIRMED THAT THE PROBLEM OCCURRED FIRST THING IN THE MORNING WHEN THE MEDICAL STAFF ATTEMPTED TO LOG IN TO THE HEMO APPLICATION. IT WAS ALSO CONFIRMED THAT NO PATIENT WAS PRESENT WHEN THE PROBLEM OCCURRED. DUE TO THE HEMO MONITOR NOT FUNCTIONING AS EXPECTED, THERE IS A POTENTIAL FOR A DELAY IN DIAGNOSIS OR TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385199 MERGE HEMODYNAMICS PROGRAMMABLE DIAGNOSTIC COMPUTER DQK MERGE HEALTHCARE MERGE HEMODYNAMICS 9.40.1

    Patients

    Seq Age Sex Outcome Treatment
    1