BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 RMT SYSTEM

    MDR report key: 2721926 · Received August 30, 2012

    Report

    Report Number
    3008203003-2012-00034
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE REPAIR RECORD IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT UPON POWERING UP THE CARTO 3 PIU, THERE WAS NOISE ON ALL CHANNELS. AFTER FOLLOW UP TO CLARIFY THE EVENT, IT WAS CONFIRMED THAT THE LOST OF SIGNALS OCCURRED IN THE 12 LEADS OF BS ECGS AND ALL IC RECORDINGS IN BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME. THE CARTO 3 RMT SYSTEM WAS INSPECTED BY BWI SERVICE ENGINEER. THE SYSTEM RECENTLY HAD AN ECG CARD REPLACED DUE TO SALINE BEING DUMPED ON THE PIU A FEW WEEKS PRIOR. IT WAS FOUND THAT THE DEFECTIVE REPROCESSED CATHETER EXTENSION CABLES CAUSED THE ISSUE. THE USER HAD A NUMBER OF SUCH DEFECTIVE CABLES. THE CABLES WERE REPLACED WITH NEW ONES AND THE ISSUE RESOLVED. THE ENTIRE PIU WAS RECENTLY REPLACED DUE TO DUE TO SALINE BEING ACCIDENTALLY DUMPED ON THE PIU. LATER ON THE PIU WAS INSPECTED, AND NO INTERNAL DAMAGE WAS FOUND. THE PIU WAS TESTED AND WAS FOUND IN ACCEPTABLE CONDITION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POWERING UP THE CARTO 3 PIU, THERE WAS NOISE ON ALL CHANNELS. THE CALL WAS TRANSFERRED TO THE CLINICAL SPECIALIST FOR FURTHER ASSISTANCE. THE CLINICAL SPECIALIST STATED THAT WHEN THE PIU WAS POWERED OFF, THE NOISE WAS RESOLVED ON ALL IC AND BS CHANNELS. THE REPORTER WAS NOT IN THE PROCEDURE ROOM WHERE THE CASE WAS IN PROGRESS. THE REPORTER WAS ADVISED TO CHECK/REPLACE THE RIGHT LEG (RL) LEAD TO THE PATIENT, EXCHANGE THE CATHETER CABLES AND ANY REPROCESSED CATHETERS. THE REPORTER ALSO MOVED THE LOCATION PAD FROM UNDER THE TABLE TO SEE IF THE NOISE IMPROVED AND CALLS BACK WITH RESULTS. THE CASE CONTINUED WITHOUT CARTO 3 USAGE. AFTER FOLLOW UP TO CLARIFY THE EVENT, IT WAS CONFIRMED THAT THE LOST OF SIGNALS OCCURRED IN THE 12 LEADS OF BS ECGS AND ALL IC RECORDINGS IN BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME. THE NOISE WAS DESCRIBED AS SEVERE HIGH AMPLITUDE/HIGH FREQUENCY AND THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE SIGNALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-5830-01

    Patients

    Seq Age Sex Outcome Treatment
    1