BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4164352 · Received October 10, 2014

    Report

    Report Number
    3008203003-2014-00064
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A CARTO® 3 SYSTEM AND NOISE WAS OBSERVED ON ALL CHANNELS. THE PIN BOX WAS REPORTED TO BE FAULTY, CAUSING NOISE ON ALL CHANNELS AND IN BOTH SYSTEMS, EP RECORDING AND CARTO 3. THE PROCEDURE WAS COMPLETED CONVENTIONALLY WITH NO PATIENT CONSEQUENCES. THE PHYSICIAN DID NOT HAVE AN AVAILABLE SIGNAL TO MONITOR PATIENT'S HEART RHYTHM. DUE TO THIS, IT WAS DETERMINED FOR THIS EVENT TO BE REPORTABLE. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. THE ACCOUNT RECEIVED A NEW PIN BOX. THE PROBLEM WAS RELATED TO DEFECTIVE PIN BOX. THE SYSTEM IS READY TO USE AND FUNCTIONAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. 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. THE CUSTOMER COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A CARTO® 3 SYSTEM AND NOISE WAS OBSERVED ON ALL CHANNELS. THE PIN BOX WAS REPORTED TO BE FAULTY, CAUSING NOISE ON ALL CHANNELS AND IN BOTH SYSTEMS, EP RECORDING AND CARTO 3. THE PROCEDUE WAS COMPLETED CONVENTIONALLY WITH NO PATIENT CONSEQUENCES. THE PHYSICIAN DID NOT HAVE AN AVAILABLE SIGNAL TO MONITOR PATIENT'S HEART RHYTHM. DUE TO THIS, IT WAS DETERMINED FOR THIS EVENT TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644423 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1