BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3230202 · Received July 16, 2013

    Report

    Report Number
    3008203003-2013-00089
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED DUO DECA CATHETER WAS PLUGGED INTO THE REF DECA PORT, THE 12 LEADS SIGNALS WERE LOST AND ALL INTRACARDIAC SIGNALS HAD A LOT OF NOISE ON THE CARTO 3 AND THE RECORDING SYSTEM. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT PORT. ADDITIONAL INFORMATION PROVIDED STATED SIGNAL LOSS OCCUR ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE AND ALL IC (INTRACARDIAL) RECORDINGS. NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET NEITHER THE BODY SURFACE NOR ANY IC RECORDINGS DUE TO THE NOISE. AFTER UNIT EVALUATION, FIELD SERVICE ENGINEER WAS ABLE TO DUPLICATE THE ISSUE. FIELD SERVICE ENGINEER REPLACED BACK PLANE CARD AND ISSUE WAS RESOLVED. SYSTEM WAS TESTED AND SYSTEM WAS FUNCTIONING PER SPECIFICATION. THE DEFECTIVE CARD WAS SENT FOR FURTHER TESTING. IT WAS DETERMINED THE DEFECTIVE DIODE D15 CAUSED THE REPORTED PROBLEM. THE CARD WAS SENT TO SUBCONTRACTOR FOR REPAIR. THE CUSTOMER COMPLAINT WAS CONFIRMED. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED DUO DECA CATHETER WAS PLUGGED INTO THE REF DECA PORT, THE 12 LEADS SIGNALS WERE LOST AND ALL INTRACARDIAC SIGNALS HAD A LOT OF NOISE ON THE CARTO 3 AND THE RECORDING SYSTEM. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT PORT. ADDITIONAL INFORMATION PROVIDED STATED SIGNAL LOSS OCCUR ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE AND ALL IC (INTRACARDIAL) RECORDINGS. NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET NEITHER THE BODY SURFACE NOR ANY IC RECORDINGS DUE TO THE NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328853 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1