BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3163471 · Received June 11, 2013

    Report

    Report Number
    3008203003-2013-00071
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 27, 2013
    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

    (B)(4),

    Additional Manufacturer Narrative · 1

    (B)(4) DURING THE PROCEDURE, IT WAS REPORTED DURING ABLATION, THE ELECTRICAL POTENTIALS OF THE BODY SURFACE ECG SUDDENLY DISAPPEARED. ADDITIONALLY, THE ELECTRICAL POTENTIALS OF INTRACARDIAL THAT WAS ATTACHED TO CARTO BECAME NOISE AND COULD NOT BE INTERPRETED. THE FOLLOWING TROUBLESHOOTING WAS PERFORMED BUT COULD NOT IMPROVE THE SITUATION; ECG-IN CABLE WAS RECONNECTED. RE-OPENING THE STUDY FILE. WORKSTATION REBOOT. THE PROCEDURE WAS CARRIED ON WITHOUT USING CARTO. AFTER ABOUT AN HOUR, DURING THE PROCEDURE, IT WAS FOUND CARTO BECAME AVAILABLE WHEN THE ECG-IN CABLE WAS RECONNECTED AS WELL AS RE-OPENED THE STUDY FILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN WAS NOT ABLE TO INTERPRET BOTH THE BODY SURFACE ECGS AND ALL IC RECORDINGS DUE TO THE NOISE ISSUE. THE SYSTEM WAS SENT TO REPAIR CENTER FOR FURTHER EVALUATION IT WAS DETERMINED THE REPORTED ISSUES WEREN'T DUPLICATED. THE SYSTEM PASSED ATP, FUNCTIONAL TEST AND ELECTRICAL SAFETY TEST. THE SYSTEM WAS FUNCTIONING PER SPECIFICATION. CUSTOMER¿S COMPLAINT CANNOT BE CONFIRMED. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED DURING ABLATION, THE ELECTRICAL POTENTIALS OF THE BODY SURFACE ECG SUDDENLY DISAPPEARED. ADDITIONALLY, THE ELECTRICAL POTENTIALS OF INTRACARDIAL THAT WAS ATTACHED TO CARTO BECAME NOISE AND COULD NOT BE INTERPRETED. THE FOLLOWING TROUBLESHOOTING WAS PERFORMED BUT COULD NOT IMPROVE THE SITUATION; ECG-IN CABLE WAS RECONNECTED. RE-OPENING THE STUDY FILE. WORKSTATION REBOOT. THE PROCEDURE WAS CARRIED ON WITHOUT USING CARTO. AFTER ABOUT AN HOUR, DURING THE PROCEDURE, IT WAS FOUND CARTO BECAME AVAILABLE WHEN THE ECG-IN CABLE WAS RECONNECTED AS WELL AS RE-OPENED THE STUDY FILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN WAS NOT ABLE TO INTERPRET BOTH THE BODY SURFACE ECGS AND ALL IC RECORDINGS DUE TO THE NOISE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264327 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) FG-5400-00M

    Patients

    Seq Age Sex Outcome Treatment
    1