BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-RADIOFREQUENCY CABLE

    MDR report key: 3134515 · Received May 24, 2013

    Report

    Report Number
    9710452-2013-00006
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 27, 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 IS PENDING. IF ANY ADD'L INFO RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE DEICE HISTORY RECORD REVIEW, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE WHERE ALL OF THE PROBES WERE PLUGGED INTO THE NECESSARY PORTS AND THE PT WAS GROUNDED, THE MACHINE DISPLAYED HIGH IMPEDANCE. THE GROUNDING PAD AND PROBES WERE CHANGED. THE MACHINE CONTINUED TO DISPLAY HIGH IMPEDANCE. THERE WAS NO PT INJURY AND THE PROCEDURE WAS NOT COMPLETED. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2013-00021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230591 MULTI-RADIOFREQUENCY CABLE RF CABLE GXI BAYLIS MEDICAL CO., INC. PMX-BAY-MRF PXFA220612

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR