MalfunctionPJB
CARDIODRIVE MOTOR
Received May 31, 2023 · Event occurred May 12, 2023
Report 17029987 · MDR key 17029987
Device
Generic name
Catheter Remote Control System
Manufacturer
Stereotaxis, IncModel number
030-005115-8Catalog number
030-005115-8
Product problems
- Mechanical Problem
Patient
23725 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
MOTOR MALFUNCTION ON CARDIO DRIVE MOTOR OF STEREOTAXIS, IN ELECTROPHYSIOLOGY (EP) LAB. THIS CREATED A DELAY IN THE CASE AND A DIFFERENT APPROACH TO PROCEED WITH THE PROCEDURE WAS USED. EXPENSIVE MATERIALS WERE WASTED DUE TO THE MALFUNCTION AS WELL.