BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3102904 · Received May 9, 2013

    Report

    Report Number
    3008203003-2013-00062
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. MANUFACTURER'S REF. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MAG LOCATION AND ACL CARDS WERE REPORTING RED BIT LED DISPLAYED. THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THEY WERE UNABLE TO START THE PROCEDURE. THE CASE CANCELLATION WAS ONLY BECAUSE OF THIS SYSTEM ISSUE. THE PATIENT REQUIRED 7 EXTRA DAYS OF HOSPITALIZATION BECAUSE OF THIS PROCEDURE CANCELLATION AS THEY WERE AWAITING THE REPAIR OF THE CARTO 3 SYSTEM. REPLACING THE DC/DC CARD RESOLVED THE ISSUE. THIS CARD WAS SENT TO THE CARTO MANUFACTURER (HTC) FOR FURTHER INVESTIGATION. HTC TESTED THE CARD AND REPORTED THAT THE CUSTOMER COMPLAINT WAS CONFIRMED. THE CARD FAILED DUE TO DEFECTIVE COMPONENT (VOLTAGE CONVERTER) THAT CAUSED THE REPORTED ABOVE PROBLEM. ONCE THE COMPONENT WAS REPLACED, THE CARD RETURNED TO PROPER FUNCTIONING. 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 DURING AN ATRIAL TACHYCARDIA (AT) PROCEDURE, ERROR CODES 18 (PATIENT INTERFACE UNIT - PIU TOO HOT) AND 27 (THE PATIENT INTERFACE UNIT-PIU BUILT- IN TEST FAILED/FAILURE IN THE POWER CARD) OCCURRED. MAG LOCATION AND ACL CARDS WERE REPORTING RED BIT LED DISPLAYED. THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THEY WERE UNABLE TO START THE PROCEDURE. THE CASE CANCELLATION WAS ONLY BECAUSE OF THIS SYSTEM ISSUE. THE PATIENT REQUIRED 7 EXTRA DAYS OF HOSPITALIZATION BECAUSE OF THIS PROCEDURE CANCELLATION AS THEY WERE AWAITING THE REPAIR OF THE CARTO 3 SYSTEM. SINCE THE PATIENT REQUIRED THIS EXTENDED HOSPITALIZATION AS THE PROCEDURE WAS CANCELLED DUE TO THIS SYSTEM ISSUE, THIS IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204160 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1