BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREOTAXIS

    MDR report key: 17641166 · Received August 29, 2023

    Report

    Report Number
    17641166
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 15, 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

    IMAGE QUALITY OF OUR X-RAY MACHINE WAS VERY FUZZY AND COULD NOT SEE THE CATHETER WHILE FLOURING. DUE TO THE IMAGE QUALITY, WE HAD TO USE HIGHER DOSE OF RADIATION, WHICH IT CAUSES THE ANODE INSIDE THE MACHINE TO OVERHEAT. AFTER THE OVERHEATING OF THE MACHINE, IT WOULD NOT ALLOWED US TO USE THE X-RAY. PROCEDURE WAS COMPLETED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958953 STEREOTAXIS CATHETER REMOTE CONTROL SYSTEM PJB STEREOTAXIS, INC CS20

    Patients

    Seq Age Sex Outcome Treatment
    1 32850 DA Unknown