BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO XP SYSTEM

    MDR report key: 1371177 · Received February 12, 2009

    Report

    Report Number
    9681484-2009-00009
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    December 19, 2008
    Report Date
    January 9, 2009
    Manufacturer
    BIOSENSE WEBSTER, LTD. (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN AUTHORIZED SERVICE ENGINEER VISITED THE SITE AND FOUND THAT THE MAGNETIC FIELD DISTORTION WAS CAUSED BY THE INTENSIFIER HEAD MOVED TOO NEAR TO THE CATHETER AND ALSO A METAL BAR WAS ALSO ATTACHED TO THE TOP OF THE BED WHICH HAD SINCE BEEN REMOVED. NO DISCREPANCY ON THE CARTO WAS NOTED AND THE SYSTEM FUNCTIONED MEETING ALL SPECIFICATIONS. RELEVANT WARNINGS AND INSTRUCTIONS ARE INDICATED IN THE USER MANUAL AND ARE PROVIDED DURING ON-SITE TRAINING. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAF PROCEDURE, THE MAPPING CATHETER SHIFTED DUE TO METAL DISTORTION WHERE THE INTENSIFIER HEAD (JW: X-RAY) WAS MOVED TOO NEAR TO THE CATHETER AND ALSO A METAL BAR WAS ATTACHED TO THE TOP OF THE BED. THERE WAS NO PATIENT INJURY REPORTED. THE PT HAS COMPLETELY RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR