BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER CARTO

    MDR report key: 13118659 · Received December 29, 2021

    Report

    Report Number
    MW5106382
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 28, 2021
    Manufacturer
    JOHNSON & JOHNSON / BIOSENSE WEBSTER (ISRAEL), LTD.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CARDIAC ABLATION, THE MAPPING SYSTEM WENT DOWN. THE CATHETER AND THE HANDLE WERE BOTH REPLACED A COUPLE TIMES BUT WAS STILL NOT WORKING PROPERLY. THE CASE WAS ABORTED AND IT WAS FOUND THAT THE SYSTEM NEEDED A SOFTWARE UPDATE. THIS UPDATE WAS COMPLETED FOLLOWING THE CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014034 BIOSENSE WEBSTER CARTO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK JOHNSON & JOHNSON / BIOSENSE WEBSTER (ISRAEL), LTD. FG540000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female