BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 14794442 · Received June 23, 2022

    Report

    Report Number
    3019751610-2022-00009
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    UDI-DI
    00685447000969
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT OCCURRED. DHR REVIEW WAS COMPLETED AND THE DEVICE FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    A 25-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR PRODUCED AN ERROR AND FAILED TO DELIVER RF ENERGY. AFTER THE FIRST FAILED ATTEMPT, THE RF DEVICES WERE DISCONNECTED AND RECONNECTED. A SECOND ATTEMPT WAS MADE TO DELIVER RF ENERGY, BUT THE ERROR CODE OCCURRED AGAIN. A MECHANICAL DEVICE USED FOR THE TRANSSEPTAL PROCEDURE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY THAT RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691433 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI BAYLIS MEDICAL COMPANY INC. RFP-100A 00685447000969

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other