BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5061186 · Received September 8, 2015

    Report

    Report Number
    3008203003-2015-00072
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER'S REF. NO:(B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO 3 SYSTEM AND NO ERROR MESSAGE POPULATED WHEN A MAP SHIFT OCCURRED. THE PATIENT WAS NOT MOVING AT ALL. HOWEVER, MAP1 AND MAP2 ARE DIFFERENT. THE MAP DRAWINGS WERE COMPARED WITH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER TESTED THE SYSTEM. ENVIRONMENTAL EVALUATION AND CALIBRATION TESTS WERE PERFORMED AND PASSED SPECIFICATIONS. THE ISSUE WAS NOT DUPLICATED. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER CONFIRMED THAT THE SYSTEM IS OPERATIONAL. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD SIGNAL POLARITY REVERS ISSUE. THE SYSTEM WAS TESTED ACCORDING TO THE MANUAL AS WELL AS THE PRUCKA RECORDING SYSTEM. IT WAS DETERMINED THAT THE ROOT CAUSE WAS THE PRUCKA RECORDING SYSTEM SOFTWARE SETTINGS. AFTER THE PRUCKA RECORDING SYSTEM SETTINGS WERE READJUSTED, THE ISSUE WAS SOLVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO 3 SYSTEM AND NO ERROR MESSAGE POPULATED WHEN A MAP SHIFT OCCURRED. THE PATIENT WAS NOT MOVING AT ALL. HOWEVER, MAP1 AND MAP2 ARE DIFFERENT. THE MAP DRAWINGS WERE COMPARED WITH FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THERE IS A POTENTIAL RISK TO PATIENT WHEN SUCH MAP SHIFTS OCCUR WITHOUT AN ERROR MESSAGE. THEREFORE, THIS ISSUE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594103 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1