BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ PRECISION¿ SOFTWARE

    MDR report key: 7004232 · Received November 6, 2017

    Report

    Report Number
    2184149-2017-00048
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K160210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CASE STUDY LOGS DID NOT REVEAL ANY SOFTWARE ISSUES AND THERE WERE NO ERROR MESSAGES CORRELATING TO THE NON-ABBOTT REMOTE MONITOR. FURTHER INFORMATION INDICATED THAT THE SITE HAD ADJUSTED THE REMOTE MONITOR CONFIGURATION IN ATTEMPTS TO WORK WITH NON-ABBOTT DISPLAY HARDWARE. FURTHER COMMUNICATION WITH THE CUSTOMER REVEALED THE ISSUE WAS RESOLVED THE FOLLOWING DAY BY THE ALTERING THE RESOLUTION SETTING ON THE REMOTE MONITOR.

    Description of Event or Problem · 1

    DURING A COMPREHENSIVE ELECTROPHYSIOLOGY STUDY WITH ARRHYTHMIA INDUCTION, THE SLAVE IMAGE FROZE. BY CHANGING SCREENS THE IMAGE WOULD BECOME LIVE FOR THIRTY SECONDS AND THEN FREEZE AGAIN. THE CASE WAS CONTINUED BY RESETTING THE SCREEN EVERY TIME IT FROZE. THE CASE WAS COMPLETED HOWEVER, THERE WAS SOME DELAY IN THE PROCEDURE TIME. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782540 ENSITE¿ PRECISION¿ SOFTWARE ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM DQK ST. JUDE MEDICAL, INC. H702496

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other