BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR

    MDR report key: 15285178 · Received August 24, 2022

    Report

    Report Number
    3019751610-2022-00020
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 24, 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
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A PROCEDURAL ABORTION WAS REPORTED IN A CASE WHERE THE BAYLIS RADIOFREQUENCY PUNCTURE GENERATOR (RF GENERATOR) WAS UNABLE TO BE USED FOR A TRANSSEPTAL PROCEDURE. THE RF GENERATOR PRODUCED AN ERROR AND WAS UNABLE TO REBOOT. NO OTHER RF GENERATOR WAS AVAILABLE FOR THE PROCEDURE. ANOTHER MEANS OF TRANSSEPTAL WAS NOT CONSIDERED AND THE PROCEDURE WAS ABORTED. WHILE THERE WAS NO PATIENT INJURY REPORT, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE PROCEDURAL ABORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829256 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