BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 4647769 · Received March 31, 2015

    Report

    Report Number
    2183926-2014-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 21, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MERGE HEALTHCARE, INC
    Product Code
    DQK
    PMA / PMN Number
    K082421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE MERGE HEMO SYSTEM IS COMPRISED OF TWO OFF THE SHELF PCS AND A PT DATA MODULE TO PROVIDE VITALS MONITORING. ONE OF THE PCS IS USED TO RECORD DATA IS A PT'S ELECTRONIC MEDICAL RECORD. THE SECOND PC IS USED TO DISPLAY THE DATA AN WAVEFORMS RECEIVED FROM THE PT DATA MODULE. THIS PC IS REFERRED TO AS THE HEMO MONITOR PC. IT WAS BROUGHT TO THE ATTENTION OF MERGE HEALTHCARE THAT THE HEMO MONITOR EXPERIENCED A RANDOM CRASH DURING A CARDIAC CATH CASE. THE ERROR WAS INITIALLY REPORTED AS AN ISOLATED INCIDENT IN (B)(6) 2013. THE ERROR WAS UNREPRODUCIBLE BY MERGE HEALTHCARE AND WAS NOT REPORTED FROM THE FIELD AS OCCURRING AGAIN. ON (B)(6) 2014, THE ERROR WAS REPORTED AGAIN. THE HEMO MONITOR PC INTERMITTENTLY CRASHED AND DISPLAYED AN ERROR READING "HEMOMONITOR.EXE HAS STOPPED WORKING UNEXPECTEDLY." THE ISSUE HAS SINCE BEEN REPORTED MULTIPLE TIMES FROM SEVERAL CUSTOMER SITES. ENGINEERING HAS BEEN WORKING DILIGENTLY RESEARCHING THE ERROR AND TRYING TO REPRODUCE SINCE (B)(6). TWO SITES HAVE RETURNED PCS TO MERGE FOR EVAL. AT THIS TIME, MERGE IS UNABLE TO REPRODUCE OR FIND A ROOT CAUSE. AFTER CRASH, THE HEMO MONITOR IS ABLE TO BE BROUGHT RIGHT BACK UP, MINIMIZING THE TIME A SITE IS WITHOUT REAL TIME WAVEFORMS. THE MERGE HEMO SYSTEM ALSO HAS THE ABILITY TO INTERFACE WITH THIRD PARTY MONITORS TO ENSURE THE PT'S VITAL SIGNS MAY STILL BE MONITORED AND RECORDED DURING THE OUTAGE. AT THIS TIME, THE ISSUE IS SUSPECTED TO BE CAUSED BY THE OPERATING SYSTEM UPGRADED FROM WINDOWS XP TO WINDOWS 7 64-BIT. PRIOR TO THIS UPGRADE, THERE WERE NO REPORTS OF THE HEMO MONITOR CRASHING THIS WAY. ONCE A ROOT CAUSE IS FOUND, MERGE WILL CORRECT THE ISSUE IN THE NEXT PLANNED REVISION OF SOFTWARE. AT THIS TIME, MERGE WILL PROVIDE A CUSTOMER NOTIFICATION TO SITES WITH VERSION 9 WINDOWS 7 HEMO MONITOR PC DETAILING THE ISSUE, HOW TO RESTART AND HOW TO CONTACT SUPPORT IF MORE INFO IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211101 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE, INC 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1