BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO XP EP NAVIGATION SYSTEM

    MDR report key: 1032443 · Received April 16, 2008

    Report

    Report Number
    9681484-2008-00006
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SOFTWARE FAILURE. THE SYSTEM HAD A MAP SHIFT. NO PATIENT INJURY WAS REPORTED.

    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 NI