inforMED
MalfunctionPJB

STEREOTAXIS

Received Aug 29, 2023 · Event occurred Jul 13, 2023

Report 17641166 · MDR key 17641166

Device

Generic name

Catheter Remote Control System

Manufacturer

Stereotaxis, Inc

Model number

CS20

Patient

32850 DA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.