BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 12278842 · Received August 5, 2021

    Report

    Report Number
    9710452-2021-00038
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 5, 2021
    Product Code
    GEI
    UDI-DI
    00685447000969
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DELAY THAT OCCURRED. DHR REVIEW WAS COMPLETED AND THE DEVICE FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A 20-MINUTE PROCEDURAL DELAY WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR PRODUCED AN ERROR AND WAS UNABLE TO REBOOT. ANOTHER GENERATOR WAS USED FOR THE PROCEDURE. 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
    1182252 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR RADIOFREQUENCY GENERATOR GEI RFP-100A 00685447000969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other