BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO

    MDR report key: 6120196 · Received November 22, 2016

    Report

    Report Number
    6120196
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 10, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EP CASE, NOISE COMING FROM DEVICE. CABLES AND CONNECTORS CHECKED. UNABLE TO IDENTIFY CAUSE OF NOISE. REMOVED ITEM FROM FIELD AND REPLACED WITH SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771666 SOUNDSTAR ECO CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER, INC. 10439011 10846835008852

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR