BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO¿ 3 SYSTEM

    MDR report key: 2083322 · Received May 10, 2011

    Report

    Report Number
    9681484-2011-00005
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO THIS COMPLAINT, THE BWI REPRESENTATIVE REMOVED THE BARD QUICK CONNECT CABLE AND THE ISSUE CLEARED UP. THE BWI REPRESENTATIVE ALSO CHECKED THE CONNECTIVITY BETWEEN THE BARD AND CARTO 3 SYSTEM, HOWEVER ISSUE COULD NOT BE DUPLICATED. THE CARTO 3 SYSTEM HAS BEEN USED TWICE SINCE ISSUE WAS CALLED IN WITH NO PROBLEMS BETWEEN THE BARD AND CARTO 3 SYSTEM. CARTO 3 SYSTEM WAS READY FOR USE.THE DHR ASSOCIATED WITH CARTO (B)(4) WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTO 3 AND THE BARD EP RECORDING SYSTEM WAS RANDOMLY LOSING BOTH INTRACARDIAC AND BODY SURFACE EKGS. THESE LOSSES ALSO EFFECTED THE BARD RECORDING SYSTEM. THE CASE WAS STARTED WITH DIRECT CONNECT CABLES. CHANGING TO IC OUT CABLES DID NOT RESOLVE THE ISSUE. THE CARTO 3 AND BARD WERE REBOOTED BUT THE BEHAVIOR CONTINUED. THE CARTO WAS BYPASSED AND THE EKGS WERE CLEAN ON THE BARD SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1