BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2914502 · Received January 14, 2013

    Report

    Report Number
    3008203003-2013-00010
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE THERE WAS NOISE ON ALL CHANNELS BOTH BS AND IC (INTERCARDIAC) RECORDINGS. THE CABLES WERE EXCHANGED HOWEVER THE NOISES WERE NOT ELIMINATED SUCCESSFULLY. BY REPLACING FOR A NEW ECG CABLE FROM THE FRONT OF THE PIU WAS THE ONLY THING THAT HELPED THE PHYSICIAN TO PROCEED WITH THE CASE. IT WAS ALSO NOTED THAT THE ECG CARD 1 WAS RECENTLY REPLACED. LATER, DURING FURTHER CASE, THERE WERE SQUARE WAVE SIGNALS ON ALL THE CHEST LEADS. REBOOTING THE PIU AND WORKSTATION RESOLVED THE ISSUE. THE FIELD SERVICE ENGINEER ARRIVED AT THE HOSPITAL AND REPLACED THE MAIN MODULE. AFTER REPLACEMENT THERE WERE NO ISSUES WITH NOISE DURING FURTHER CASES. THE MAIN MODULE WAS SENT TO CARTO MANUFACTURER (HTC). HTC TESTED THE MAIN MODULE AND REPORTED THAT THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE MODULE PASSED ACCEPTANCE TEST PROCEDURE TESTS FOR ECG CARD. ALL SIGNALS HAD NORMAL FORMS (SQUARE WAVES WAS NOT VISIBLE). NO FAILURE WAS FOUND. THE DHR ASSOCIATED WITH CARTO 3 (B)(4) WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THERE WAS NOISE ON ALL CHANNELS BOTH BS AND IC (INTERCARDIAC) RECORDINGS. THE CABLES WERE EXCHANGED HOWEVER THE NOISES WERE NOT ELIMINATED SUCCESSFULLY. BY REPLACING FOR A NEW ECG CABLE FROM THE FRONT OF THE PIU WAS THE ONLY THING THAT HELPED THE PHYSICIAN TO PROCEED WITH THE CASE. IT WAS ALSO NOTED THAT THE ECG CARD 1 WAS RECENTLY REPLACED. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, IT WAS CONFIRM THAT ALSO THE NOISE OCCURRED ON BOTH SYSTEMS (CARTO 3 AND EP) AT THE SAME TIME. THE NOISE WAS INTERMITTENT BUT DISRUPTED THE ABILITY TO SEE ELECTROGRAMS, ESPECIALLY DURING PACING. THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE SIGNALS WITH THE PRESENCE OF NOISE. THE PACING WAS NOT FOR EMERGENCY USE. THE PHYSICIAN MANAGED TO PACE DESPITE THE NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20195 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1