BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252001 NIM-RESPONSE 2.0

    MDR report key: 2910470 · Received January 11, 2013

    Report

    Report Number
    1045254-2013-00030
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 19, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2012. THE SOUND OF THE EMG TONE FADED OUT. ADDITIONAL INFORMATION RECEIVE (B)(4) 2013, INDICATED THAT THIS WAS AN IN-HOUSE UNIT AND THERE WAS NO PATIENT INVOLVEMENT. THE EMG WAS UNABLE TO BE HEARD. (B)(4). DEVICE RETURNED (B)(4) 2012. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. EVALUATION COULD NOT CONFIRM THE REPORTED ISSUE. THE CPU BATTERY WAS OUT OF SPECIFICATION AND WAS REPLACED, HOWEVER THIS WAS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY CAUSE OF THE EVENT IS CONSIDERED TO BE A USABILITY ISSUE RELATED TO THE SYSTEM'S AUDIO.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT HAS NOT YET BEEN RETURNED H6 CODES: THE DEVICE WAS NOT YET RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    THE SOUND OF THE EMG TONE FADED OUT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013, INDICATED THAT THIS WAS AN IN-HOUSE UNIT AND THERE WAS NO PATIENT INVOLVEMENT. THE EMG WAS UNABLE TO BE HEARD.

    Description of Event or Problem · 1

    THE SOUND OF THE EMG TONE FADED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16471 MAINFRAME 8252001 NIM-RESPONSE 2.0 STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8252001 54869700

    Patients

    Seq Age Sex Outcome Treatment
    1