BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL DISC ELECTRODE

    MDR report key: 3851600 · Received April 18, 2014

    Report

    Report Number
    3008289288-2014-00002
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    May 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    GXY
    PMA / PMN Number
    K850108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. LOW AMPLITUDE SIGNAL IS A NON-SPECIFIC FINDING THAT MUST BE INTERPRETED BY THE PHYSICIAN WITH RESPECT TO THE PT'S COMPLAINTS, PHYSICAL FINDINGS, AND EMG TESTING PARAMETERS. PROPER EMG TEST PROTOCOLS MUST BE FOLLOWED TO ENSURE ACCURACY OF RESULTS. FALSE LOW AMPLITUDE SIGNALS RESULTING FROM EMG MOTOR NERVE STUDIES MAY RESULT FROM IMPROPER ELECTRODE PLACEMENT, INADEQUATE SKIN PREPARATION, OR OTHER INAPPROPRIATE USE OF THE DEVICE, AS WELL AS FROM EQUIPMENT FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEEING LOW AMPLITUDES IN MOTOR NERVE CONDUCTION STUDIES WHILE USING A NATUS 6030 REUSABLE DISC SURFACE ELECTRODE. THE FAILURE WAS OBVIOUS TO THE USER AND NOT PT INJURY WAS REPORTED. NATUS IS REPORTING THIS MDR AS A PRECAUTIONARY REPORT BASED ON A SIMILAR COMPLAINT, CUS-18420, MDR REPORT NUMBER: 3008289288-2013-00007, IN WHICH A PHYSICIAN WAS CONDUCTING AN ELECTRODIAGNOSTIC EXAMINATION AND MISDIAGNOSED A PT BASED ON LOW AMPLITUDE OF RESPONSES IN A MOTOR NERVE CONDUCTION STUDY, USING A SIMILAR ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238483 STAINLESS STEEL DISC ELECTRODE REUSABLE DISK ELECTRODE GXY NATUS NEUROLOGY INCORPORATED 6030-3-TP

    Patients

    Seq Age Sex Outcome Treatment
    1