BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARASTAR RECORDING SYSTEM MODULE EGM INPUT MODULE

    MDR report key: 20041096 · Received August 22, 2024

    Report

    Report Number
    2124215-2024-52254
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 16, 2024
    Report Date
    January 29, 2025
    Manufacturer
    FARAPULSE, INC.
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON DEVICE RETURN THE ECG OUTPUT MODULE WAS CONNECTED TO THE GOLD STANDARD FARASTAR, OPAL HDX, MSM, RSM SETUP TO VERIFY FUNCTIONALITY. A SQUARE WAVE WAS INPUT TO THE ECG CHANNELS VIA A FUNCTION GENERATOR. THE RSM WAS THEN BLANKED WITH THE MANUAL SWITCH AND THEN UN-BLANKED AND THE SIGNALS RETURNED TO NORMAL. NO INTERMITTENT SIGNALS WERE NOTED DURING TESTING, AND NO NOISE WAS OBSERVED. THE MODULE WAS THEN TESTED TO VERIFY CONTINUITY. ALL CHANNELS PASSED THIS TEST AND SHORTED WITH THE EXPECTED PINOUTS. THE INTERMITTENT SIGNAL AND NOISE REPORTED IN THE COMPLAINT WAS LIKELY CAUSED BY A POOR CONNECTION IN THE SETUP OR BY AN OUTSIDE DISTURBANCE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FARASTAR RECORD SYSTEM MODULE (RSM) LOSS OF PATIENT MONITORING SIGNALS OCCURRED. DURING A PROCEDURE A FARASTAR RECORD SYSTEM MODULE (RSM) WAS SELECTED FOR USE. DURING PREPARATION IT WAS NOTED THAT THE ECG SUDDENLY COMPLETELY DISAPPEARED. TROUBLESHOOTING WAS PERFORMED, IT WAS TRIED TO EXCHANGE THE CARTO ECG, BUT ISSUE DID NOT IMPROVE. THE FARAPULSE CABLES AND BOXES DID NOT SEEM TO HAVE ANY VISIBLE DAMAGES. THEREFORE, IT WAS DECIDED TO PICK THE ECG SIGNALS DIRECTLY WITH THE CARTO ECG AND STARTED THE PROCEDURE. THIS WORKED FOR ABOUT TWO MINUTES. THEN, IT WAS SAW THAT THE V2 LEAD WAS HAVING A NOISY SIGNAL, SO IT WAS CHECKED THE CONNECTION ON THE PATIENT AND ON THE ECG OUTPUT BOX MODULE WHEN ALL SIGNALS COMPLETELY DISAPPEARED AGAIN. PROCEDURE COULD BE COMPLETED WITHOUT ANY FURTHER COMPLICATIONS AS THEY ROUTED THE ECG DIRECTLY THROUGH CARTO PIU. EGM SIGNALS WORKED FINE, FARAWAVE SIGNALS WORKED FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FARASTAR RECORD SYSTEM MODULE (RSM) LOSS OF PATIENT MONITORING SIGNALS OCCURRED. DURING A PROCEDURE A FARASTAR RECORD SYSTEM MODULE (RSM) WAS SELECTED FOR USE. DURING PREPARATION IT WAS NOTED THAT THE ECG SUDDENLY COMPLETELY DISAPPEARED. TROUBLESHOOTING WAS PERFORMED, IT WAS TRIED TO EXCHANGE THE CARTO ECG, BUT ISSUE DID NOT IMPROVE. THE FARAPULSE CABLES AND BOXES DID NOT SEEM TO HAVE ANY VISIBLE DAMAGES. THEREFORE, IT WAS DECIDED TO PICK THE ECG SIGNALS DIRECTLY WITH THE CARTO ECG AND STARTED THE PROCEDURE. THIS WORKED FOR ABOUT TWO MINUTES. THEN, IT WAS SAW THAT THE V2 LEAD WAS HAVING A NOISY SIGNAL, SO IT WAS CHECKED THE CONNECTION ON THE PATIENT AND ON THE ECG OUTPUT BOX MODULE WHEN ALL SIGNALS COMPLETELY DISAPPEARED AGAIN. PROCEDURE COULD BE COMPLETED WITHOUT ANY FURTHER COMPLICATIONS AS THEY ROUTED THE ECG DIRECTLY THROUGH CARTO PIU. EGM SIGNALS WORKED FINE, FARAWAVE SIGNALS WORKED FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312668 FARASTAR RECORDING SYSTEM MODULE EGM INPUT MODULE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR QZI FARAPULSE, INC. OEMTRACE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown