BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-RADIOFREQUENCY CABLE

    MDR report key: 3040223 · Received April 3, 2013

    Report

    Report Number
    9710452-2013-00004
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GXI
    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 AND THE ANALYSIS OF THE RETURNED DEVICE ARE PENDING. THE ROOT CAUSE IS CURRENTLY UNKNOWN AS THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT 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

    DURING A PROCEDURE WHERE THE CABLE WAS USED, THE PHYSICIAN WAS UNABLE TO GET A TEMPERATURE READING FROM THE PROBE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWN THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2013-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137430 MULTI-RADIOFREQUENCY CABLE RF CABLE GXI BAYLIS MEDICAL CO., INC. PMX-BAY-MRF PXFA011209

    Patients

    Seq Age Sex Outcome Treatment
    1