BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEM

    MDR report key: 16634726 · Received March 29, 2023

    Report

    Report Number
    16634726
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 6, 2023
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    PJB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EQUIPMENT HAD A CPU FAILURE MULTIPLE TIMES. EQUIPMENT HAD TO REBOOT COMPUTER EACH TIME TO RESTORE IMAGING. NO HARM TO PATIENT. VENDOR NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824484 STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEM CATHETER REMOTE CONTROL SYSTEM PJB STEREOTAXIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Unknown