BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 2.0 MAINFRAME

    MDR report key: 5024883 · Received August 24, 2015

    Report

    Report Number
    1045254-2015-00284
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS IN THIS REPORT ARE THE RESULT OF INFORMATION NOT PROVIDED BY THE INITIAL REPORTER OR USER FACILITY. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR AT THE (B)(4) DEPOT IN (B)(4). THERE WAS NO FAULT FOUND WITH THE DEVICE; THEREFORE, THE MOST LIKELY ROOT CAUSE IS RELATED TO OPERATIONAL CONTEXT OR USER ERROR. THE DEVICE WAS CLEANED, TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED ESTABLISHED THE USER DID NOT EXPERIENCE A VISUAL WAVEFORM AND THERE WAS NO TONE; ALTHOUGH THEY DID VISUALIZE CONFIRMATION THAT THE ELECTRODES WERE RECOGNIZED ON THE MONITORING SCREEN DURING SETUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP [TESTING] THE MAINFRAME WILL NOT STIMULATE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED ESTABLISHED THE USER DID NOT EXPERIENCE A VISUAL WAVEFORM AND THERE WAS NO TONE; ALTHOUGH THEY DID VISUALIZE CONFIRMATION THAT THE ELECTRODES WERE RECOGNIZED ON THE MONITORING SCREEN DURING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559254 NIM® 2.0 MAINFRAME ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED INC. 8252001 56342800

    Patients

    Seq Age Sex Outcome Treatment
    1