BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREOTAXIS

    MDR report key: 17078300 · Received June 7, 2023

    Report

    Report Number
    17078300
    Event Type
    Malfunction
    Date Received
    June 7, 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

    IN ANY STEREOTAXIS CASE, THE SMARTABLATE PUMP FOR CARTO WILL FUNCTION FINE FOR A FEW SECONDS UNTIL IT EVENTUALLY ALARMS FOR BUBBLES/MICROBUBBLES. BUT THERE ARE NO BUBBLES! WE HAVE TRIED SETTING IT ON DIFFERENT SURFACES, ALCOHOL SWABBING THE BUBBLE SENSOR, AND SWITCHING OUT PUMPS. SOMETHING ABOUT STEREOTAXIS CAUSES SOME SORT OF INTERFERENCE WITH THE SENSOR. WE END UP JUST NEEDING TO DO SMALL LESIONS FOR ABLATIONS OR SOMETIMES END UP NEEDING TO COMPLETELY SWITCH TACTICS TO DO MANUAL ABLATION AND SCRAP THE STEREOTAXIS ALTOGETHER.

    Description of Event or Problem · 0

    IN ANY STEREOTAXIS CASE, THE SMARTABLATE PUMP FOR CARTO WILL FUNCTION FINE FOR A FEW SECONDS UNTIL IT EVENTUALLY ALARMS FOR BUBBLES/MICROBUBBLES. BUT THERE ARE NO BUBBLES! WE HAVE TRIED SETTING IT ON DIFFERENT SURFACES, ALCOHOL SWABBING THE BUBBLE SENSOR, AND SWITCHING OUT PUMPS. SOMETHING ABOUT STEREOTAXIS CAUSES SOME SORT OF INTERFERENCE WITH THE SENSOR. WE END UP JUST NEEDING TO DO SMALL LESIONS FOR ABLATIONS OR SOMETIMES END UP NEEDING TO COMPLETELY SWITCH TACTICS TO DO MANUAL ABLATION AND SCRAP THE STEREOTAXIS ALTOGETHER. STEREOTAXIS WAS CONTACTED. THEY RECOMMENDED TAPING THE TUBING TO THE SIDE OF THE SMART ABLATE PUMP DURING STEREOTAXIS CASES, IN ORDER TO SECURE THE TUBING AND REDUCE VIBRATIONS DURING ABLATION THAT SEEM TO THEN CAUSE THE PUMP TO ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509867 STEREOTAXIS CATHETER REMOTE CONTROL SYSTEM PJB STEREOTAXIS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Male