BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 11396675 · Received March 1, 2021

    Report

    Report Number
    9710452-2021-00012
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 1, 2021
    Product Code
    GEI
    UDI-DI
    00685447000969
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    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 DELAY THAT OCCURRED.

    Description of Event or Problem · 1

    THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR SHOWED AN IMPEDANCE ERROR CODE WHEN THE NRG TRANSSEPTAL NEEDLE WAS USED TO ATTEMPT RF DELIVERY, RESULTING IN A 60-MINUTE DELAY IN THE PROCEDURE. THE NEEDLE, CONNECTOR CABLE AND GROUNDING PAD WERE EXCHANGED FOR DIFFERENT ONES, HOWEVER THE GENERATOR CONTINUED TO SHOW THE SAME ERROR CODE. THE TRANSSEPTAL PUNCTURE WAS ACHIEVED SUCCESSFULLY WITHOUT THE USE OF RADIOFREQUENCY ENERGY. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY OF 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294026 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI RFP-100A 00685447000969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other