BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM INTERFACE CABLE

    MDR report key: 3844675 · Received June 3, 2014

    Report

    Report Number
    2029046-2014-00156
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CARTO 3 SYSTEM MODEL# M-4800-01, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE SIGNAL LOST OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS ECGS AND ALL IC (INTRACARDIAC) RECORDINGS ON BOTH CARTO AND GE RECORDING SYSTEMS AT THE SAME TIME. IT WAS STATED THAT THE ECG CABLES WHERE NOT CROSSING ANY OTHER CABLES AND THEY HAD REPLACED THE GROUNDING PAD FROM THE BACK TO THE LEG WITHOUT RESOLUTION. THE CUSTOMER THEN CHANGED THE ABLATION CABLE AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324638 CARTO® 3 SYSTEM INTERFACE CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, INC (IRWINDALE) D-1286-03-S OEM_D-1286-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1