BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 20768022 · Received November 24, 2024

    Report

    Report Number
    2029046-2024-03785
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 24, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE FOR TROUBLESHOOTING AND REPAIR. THE FSE CONFIRMED THAT DURING THE VISIT, PIU INITIALIZATION CANNOT BE ESTABLISHED AND SYSTEM SHOW ERRORS 7: "LEAKAGE CURRENT DETECTED ON PIU RL INPUT" AND 27: "FAILURE IN PIU POWER CARD BIT". REPLACING THE DC/DC CARD RESOLVED BOTH ISSUES. ERROR 18: "THE PIU TEMPERATURE IS TOO HIGH" AND THE BURNING SMELL ISSUES WERE NOT CONFIRMED DURING THE VISIT AND WERE NOT DUPLICATED BEFORE AND AFTER THE DC/DC CARD REPLACEMENT. ALL ATP TESTS PASSED SUCCESSFULLY. THE SUSPECTED DC/DC CARD WAS DISCARDED AND COULD NOT BE INVESTIGATED TO DETERMINE THE SOURCE OF THE BURNING SMELL. THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM #10232 WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #10232, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A CARTO 3 SYSTEM AND INITIAL INFORMATION RECEIVED INDICATED THAT THERE WAS A LEAKAGE ERROR, AS WELL AS TEMPERATURE HIGH ERROR AND NO COMMUNICATION, ON THE PATIENT INTERFACE UNIT (PIU). THEY TURNED OFF THE PIU, DISCONNECTED ALL CABLES, REBOOTED THE PIU. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THIS ISSUE WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 29-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PRINTED CIRCUIT BOARD SMELLED BURNING NEAR TO PIU. WITH THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 29-OCT-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606687 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK CABLE.