BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2575540 · Received May 16, 2012

    Report

    Report Number
    3008203003-2012-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 23, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA WHEN ANALYSIS REPAIR IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #: (B)(4). IT WAS REPORTED THAT A HEAVY NOISE OCCURRED ON BOTH CARTO 3 AND EP RECORDING SYSTEMS AT THE SAME TIME. THE BASELINE SIGNALS WERE NOT DETECTED DUE TO THE NOISE DURING PACING AND ABLATION. THE ISSUES WERE NOT RESOLVED BY EXCHANGING THE AMPLIFIER, STIMULATOR, PIN BOX AND CABLE. THE PACING WAS CONDUCTED BY CONNECTING TO THE DIRECT PORT OF THE MAP. THE SYSTEM WAS REMOVED FROM THE ACCOUNT. THREE ECG'S CARD WERE REPLACED WITH OTHER ONES IN (B)(4) REPAIR CENTER. ATP (ACCEPTANCE TEST PROCEDURE), FUNCTIONAL TEST AND ELECTRICAL SAFETY TEST WERE PERFORMED AND THE SYSTEM WAS FOUND READY FOR USE. THE SUSPICIOUS ECG CARDS WERE TESTED BY MANUFACTURER (HTC). THE CUSTOMER COMPLAINT WAS CONFIRMED: NOISE PROBLEM WAS REPRODUCED. UPGRADE OF THE CARDS TO REVISION 07 MUST SOLVE THE PROBLEM. THE CARDS WERE SENT TO SUBCONTRACTOR FOR UPGRADE. THE DHR ASSOCIATED WITH CARTO 3 # 50036 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEAVY NOISE OCCURRED ON BOTH CARTO 3 AND EP RECORDING SYSTEMS AT THE SAME TIME. THE BASELINE SIGNALS WERE NOT DETECTED DUE TO THE NOISE DURING PACING AND ABLATION. THE ISSUES WERE NOT RESOLVED BY EXCHANGING THE AMPLIFIER, STIMULATOR, PIN BOX AND CABLE. THE PACING WAS CONDUCTED BY CONNECTING TO THE DIRECT PORT OF THE MAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) FG-5400-00M

    Patients

    Seq Age Sex Outcome Treatment
    1