BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS PAIN MANAGEMENT GENERATOR PMG-115-TD

    MDR report key: 8141118 · Received December 7, 2018

    Report

    Report Number
    8141118
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 2, 2018
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT TO THE ROOM FOR RADIOFREQUENCY ABLATION LUMBAR. DOCTOR COULD COMPLETE 1ST LEVEL OF TREATMENT AND UNABLE TO ADVANCE TREATMENT MODE TO THE 2ND AND 3RD LEVEL. DOCTOR WAS UNABLE TO CONTINUE THE PROCEDURE. UNIT IS END OF SERVICE (EOS) PER MANUFACTURER, AND WAS REMOVED FROM SERVICE AND RETIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982912 BAYLIS PAIN MANAGEMENT GENERATOR PMG-115-TD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BAYLIS MEDICAL CO., INC. PMG-115-TD

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA