BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIODRIVE MOTOR

    MDR report key: 17029987 · Received May 31, 2023

    Report

    Report Number
    17029987
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 12, 2023
    Report Date
    May 23, 2023
    Manufacturer
    STEREOTAXIS, INC
    Product Code
    PJB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131774 CARDIODRIVE MOTOR CATHETER REMOTE CONTROL SYSTEM PJB STEREOTAXIS, INC 030-005115-8

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA Female