BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3023763 · Received March 27, 2013

    Report

    Report Number
    3008203003-2013-00040
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, ERRORS 932 AND 319 APPEARED AND THE CASE WAS RESCHEDULED BECAUSE OF THE PRODUCT ISSUE. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM AND A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELLATION. THE PHYSICIAN DID NOT CONSIDER CANCELLING THE PROCEDURE CAUSED A POTENTIAL RISK TO THIS PATIENT. BIOSENSE FIELD SERVICE ENGINEERS REPORTED THAT THE ISSUE WAS NOT REPRODUCED DURING TROUBLESHOOTING AND THE CUSTOMER CONFIRMED THAT THE ISSUE COULD NOT BE REPRODUCED DURING NEXT TWO PROCEDURES. THE SYSTEM IS FULLY OPERATIONAL. SINCE THIS WAS A REPORTABLE EVENT, AN ADDITIONAL ORIGINAL EXTERNAL MANUFACTURER (OEM) ACTION (DHR REVIEW OR INVESTIGATION) WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, ERRORS 932 AND 319 APPEARED AND THE CASE WAS RESCHEDULED BECAUSE OF THE PRODUCT ISSUE. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM AND A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELLATION. THE PHYSICIAN DID NOT CONSIDER CANCELING THE PROCEDURE CAUSED A POTENTIAL RISK TO THIS PATIENT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE PROCEDURE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125968 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1