BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO XP EP NAVIGATION

    MDR report key: 561147 · Received December 22, 2004

    Report

    Report Number
    2020638-2004-00088
    Event Type
    Injury
    Date Received
    December 22, 2004
    Date of Event
    November 23, 2004
    Report Date
    November 23, 2004
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOSP STAFF INADVERTENTLY BYPASSED THE PT INTERFACE UNIT (PIU). ENERGY POSSIBLE SENT IN TWO DIFFERENT PLACES BYPASSING THE PIU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO XP EP NAVIGATION COMPUTER, DIAGNOSTIC PROGRAMMABLE DQK BIOSENSE WEBSTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO