BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 13020533 · Received December 16, 2021

    Report

    Report Number
    9710452-2021-00059
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 20-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR PRODUCED AN ERROR AND FAILED TO DELIVER RF ENERGY. TRANSSEPTAL PUNCTURE WAS COMPLETED USING A SECOND VERSACROSS RF WIRE FOLLOWING SUCCESSFUL RF DELIVERY. HOWEVER, THE ERROR CODE WAS OBSERVED AGAIN AFTER RF DELIVERY. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915171 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI RFP-100A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other