BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4233655 · Received November 6, 2014

    Report

    Report Number
    3008203003-2014-00072
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REFERENCE # (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO® 3 SYSTEM AND NOISE WAS OBSERVED ON CARTO AND EP RECORDING SYSTEM. DURING A PROCEDURE, NOISE WAS OBSERVED ON EQUIPMENT¿S. THE PRECORDIAL AND LIMB LEAD PATCHES WERE REPLACED AND THE ISSUE REMAINED. THE PRECORDIAL LEADS AND THE LIMB LEADS WERE REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE AT PRESENT, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE. PER TECHNICAL INPUT, PRECORDIAL AND LIMB LEAD PATCHES CAN AFFECT BOTH IC AND BS SIGNALS ON EQUIPMENT¿S, CARTO AND EP RECORDING SYSTEM. AS IT IS UNKNOWN IF THE PHYSICIAN WAS ABLE TO MONITOR PATIENT'S HEART RHYTHM, BWI DETERMINED TO TAKE A CONSERVATIVE APPROACH AND THEREFORE, REPORT THIS EVENT. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE CUSTOMER RECEIVED A NEW BS CABLE. THE SYSTEM IS READY FOR USE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. THE CUSTOMER COMPLAINT WAS CONFIRMED. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS THROUGH THE MONTHLY TRENDING REPORTS. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO® 3 SYSTEM AND NOISE WAS OBSERVED ON CARTO AND EP RECORDING SYSTEM. DURING A PROCEDURE, NOISE WAS OBSERVED ON BOTH EQUIPMENTS. THE PRECORDIAL AND LIMB LEAD PATCHES WERE REPLACED AND THE ISSUE REMAINED. THE PRECORDIAL LEADS AND THE LIMB LEADS WERE REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE AT PRESENT, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE. PER TECHNICAL INPUT, PRECORDIAL AND LIMB LEAD PATCHES CAN AFFECT BOTH IC AND BS SIGNALS ON BOTH EQUIPMENTS, CARTO AND EP RECORDING SYSTEM. AS IT IS UNKNOWN IF THE PHYSICIAN WAS ABLE TO MONITOR PATIENT'S HEART RHYTHM, BWI DETERMINED TO TAKE A CONSERVATIVE APPROACH AND THEREFORE, REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714391 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1