BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3514352 · Received December 11, 2013

    Report

    Report Number
    3008203003-2013-00151
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 29, 2013
    Report Date
    November 29, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE ERROR 1 - "NO COMMUNICATION WITH THE PATIENT INTERFACE UNIT (PIU) IS DETECTED", ERROR 2 - "THE PIU IS INITIALIZING", ERROR 3 - "THE PIU IS INITIALIZING APPEARED". THERE WAS NO COMMUNICATION WITH THE PIU. TROUBLESHOOTING WAS PERFORMED: REBOOT OF THE FULL SYSTEM WITH NO CABLES CONNECTED BUT THIS DID NOT SOLVE THE ISSUE. THE CASE COULD NOT BE PERFORMED AND IT WAS CANCELLED. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE ISSUE HAPPENED BEFORE STARTING THE CASE, BUT THE PATIENT WAS ALREADY ON THE TABLE. THE PATIENT STAYED UNDER GENERAL ANESTHESIA FOR ONE HOUR DUE TO THE SYSTEM MALFUNCTION, MAKING THE EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649538 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1