BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISICA 2

    MDR report key: 4780419 · Received May 8, 2015

    Report

    Report Number
    4780419
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 24, 2015
    Report Date
    May 8, 2015
    Manufacturer
    SANARUS TECHNOLOGIES, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING ROOM PREPARATION, THE VISICA 2 CRYO MACHINE MONITOR FAILED TO TURN ON. THE STAFF AND SALES REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE MACHINE WITHOUT SUCCESS. IT WAS DETERMINED THE MACHINE COULD NOT BE USED; THEREFORE, THE PHYSICIAN CANCELLED THE PATIENT'S PROCEDURE. THE MANUFACTURER CAME ON SITE AND REPLACED THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305445 VISICA 2 UNIT, CRYOSURGICAL, ACCESSORIES GEH SANARUS TECHNOLOGIES, INC. VS3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR