BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFP-100A FOOTSWITCH

    MDR report key: 12589831 · Received October 7, 2021

    Report

    Report Number
    9710452-2021-00043
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    GEI
    PMA / PMN Number
    K122278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 45-MINUTE PROCEDURAL DELAY THAT OCCURRED.

    Description of Event or Problem · 1

    THE RFP-100A FOOTSWITCH DID NOT ACTIVATE THE RFP-100A GENERATOR TO DELIVER RF ENERGY WHEN ATTEMPTING TO PERFORM A TRANSSEPTAL PROCEDURE, RESULTING IN A 45 MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS ABLE TO CONTINUE BY MANUALLY PUSHING THE BUTTON ON THE RFP-100A GENERATOR TO DELIVER RF ENERGY. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 45- MINUTE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493191 RFP-100A FOOTSWITCH RADIOFREQUENCY GENERATOR FOOTSWITCH GEI BAYLIS MEDICAL COMPANY INC. RFA-FS

    Patients

    Seq Age Sex Outcome Treatment
    1