BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-RADIOFREQUENCY MODULE

    MDR report key: 3072631 · Received April 19, 2013

    Report

    Report Number
    9710452-2013-00005
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GXD
    PMA / PMN Number
    K002389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND ANALYSIS OF THE RETURNED DEVICE IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ANALYSIS OF THE DEVICE, THE RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLIANT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING MALFUNCTION OF THE MULTI-RADIOFREQUENCY CABLE. DURING A PROCEDURE, STAFF HAD TO HOLD THE CABLE INTO THE PAIN MANAGEMENT GENERATOR (PMG) VERY TIGHTLY TO CONTINUE THE LESIONING PROCESS. WHEN STAFF TRIED TO COMPLETE A SECOND LESION, THE CABLE KEPT SHOWING ERROR WINDOWS. COMPLETION OF THE SECOND LESION WAS UNSUCCESSFUL. NO PATIENT INJURY OCCURRED ND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. PLEASE NOT THE KIMBERLY-CLARK HEALTHCARE OWN THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MANUFACTURER REPORT NUMBER: 1033422-2013-00018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169188 MULTI-RADIOFREQUENCY MODULE PAIN MANAGEMENT GENERATOR CABLE GXD BAYLIS MEDICAL CO., INC. PMX-BAY-MRF PXFA260412

    Patients

    Seq Age Sex Outcome Treatment
    1