BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDP-8

    MDR report key: 6971231 · Received October 24, 2017

    Report

    Report Number
    6971231
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 17, 2017
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBE OPENED ONTO STERILE FIELD AND PLUGGED INTO MACHINE; WOULD NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752058 VDP-8 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX KOVEN TECHNOLOGY, INC. VDP-8

    Patients

    Seq Age Sex Outcome Treatment
    1