BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2844873 · Received November 26, 2012

    Report

    Report Number
    3008203003-2012-00071
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 17, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER UNIT EVALUATION BWI FIELD SERVICE ENGINEER DETERMINED THE NOISE ISSUE WAS CAUSED BY THE 12 LEAD CABLE. AS RESULT, THE 12 LEAD CABLE WAS REPLACED FOR THE SYSTEM. THE NOISE ISSUE WAS RESOLVED. SYSTEM WAS RELEASED FOR USE. BWI FIELD SERVICE ENGINEER ALSO DISCUSSED NOISE PREVENTION TECHNIQUES WITH THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE. IN ADDITION AN EXISTING INTERNAL CORRECTIVE ACTION WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DURING THE A-FLUTTER RIGHT SIDE PROCEDURE, IT WAS REPORTED THAT A LOT OF NOISE WERE DISPLAYING ON THE ECG CHANNELS ON ALL OF THE INTRACARDIAL ELECTROGRAMS FOR BOTH THE CARTO AND EP RECORDING SYSTEMS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, STATED THE NOISE WAS ALSO PRESENT ON BODY SURFACE ECGS FOR BOTH THE CARTO AND EP RECORDING SYSTEMS. SIGNAL NOISE WAS MOST APPARENT DURING PACING. THE SIGNALS WERE IMPOSSIBLE TO BE INTERPRETED DUE TO THE PACING ARTIFACT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. BASED ON THE NEW ADDITIONAL INFORMATION, THIS EVENT IS INDICATED AS REPORTABLE. EVENT ALERT DATE WAS RESET TO (B)(4) 2012.

    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