BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 11496880 · Received March 16, 2021

    Report

    Report Number
    9710452-2021-00014
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 16, 2021
    Product Code
    GEI
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION THAT OCCURRED.

    Description of Event or Problem · 1

    THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR SHOWED A HIGH IMPEDANCE ERROR CODE WHEN THE NRG TRANSSEPTAL NEEDLE WAS USED TO ATTEMPT RF DELIVERY, RESULTING IN A PROCEDURAL ABORTION AFTER A 20-MINUTE DELAY. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394808 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI RFP-100A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention