BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO XP EP NAVIGATION SYSTEM

    MDR report key: 1021024 · Received March 27, 2008

    Report

    Report Number
    9681484-2008-00004
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    October 1, 2007
    Report Date
    October 1, 2007
    Manufacturer
    BIOSENSE WEBSTER LTD. (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K020863
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A ROUTINE AUDIT OF COMPLAINT FILES, THIS COMPLAINT WAS DISCOVERED TO HAVE NOT BEEN INADVERTENTLY SUBMITTED AS AN MDR. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER (FSE) AND PROFESSIONAL EDUCATION SPECIALIST INDICATED THAT THE CUSTOMER COMPLAINED ABOUT MAP SHIFTING DURING A PROCEDURE. THE PHYSICIAN DISCOVERED THE MAP SHIFT WITH FLUOROSCOPY DURING THE PROCEDURE. THE FSE FUNCTIONALLY TESTED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM. THE FSE DOWNGRADED THE SOFTWARE VERSION FROM 8.1.80 TO 8.1.74, RE-ENABLED THE MERGE/MAPPING UTILITIES MODULES, AND VERIFIED THAT SYSTEM PASSED THE FUNCTIONAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAP GEOMETRY HAD CHANGED ON THIS SYSTEM DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO XP EP NAVIGATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER LTD. (HAIFA, ISRAEL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1