BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2687982 · Received August 8, 2012

    Report

    Report Number
    3008203003-2012-00027
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHEN THE NAVISTAR WAS CONNECTED TO THE CARTO 3 PIU ALL SIGNALS (INTRACARDIAC AND 12-LEAD) WERE LOST ON THE EP MED RECORDING AND CARTO 3 SYSTEMS. THE ENGINEER COULD NOT DUPLICATE THE ISSUE. HOWEVER, THE PIU WAS REPLACED WITH ANOTHER ONE. THE SYSTEM PASSED THE ATP (ACCEPTANCE TEST PROCEDURE) TESTS. THE SUSPICIOUS PIU WAS SENT TO MANUFACTURER (HTC) FOR FURTHER INVESTIGATION. HTC COULDN'T REPLICATE THE REPORTED ISSUE EITHER. 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

    INVESTIGATION IS STILL IN PROCESS. A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE ANALYSIS REPAIR RECORD IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NAVISTAR WAS CONNECTED TO THE CARTO 3 PIU ALL SIGNALS (INTRACARDIAC AND 12-LEAD) WERE LOST ON THE EP MED RECORDING AND CARTO 3 SYSTEMS. THE REPORTER WAS NOT AT THE HOSPITAL AT THE TIME OF THE CALL. THE REPORTER STATED THAT THE CUSTOMER CONTINUED THE CASE WITHOUT MAPPING.

    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