BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 11177729 · Received January 15, 2021

    Report

    Report Number
    8021774-2021-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    November 23, 2020
    Report Date
    January 15, 2021
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    ETN
    PMA / PMN Number
    K923056
    Removal / Correction Number
    8021774-12182020-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION / DEVICE EVALUATION: THE COMPLAINT RECEIVED (FROM THE UNITED STATES) WAS REGARDING A BRAND NEW N100, WHERE THE COMPLAINANT REPORTED THAT THE BAR GRAPHS ON THE DEVICE DID NOT LIGHT UP AND THE DEVICE OVERALL WAS NOT WORKING. THERE WAS NO PATIENT HARM DURING THE EVENT. ON AWARENESS OF THE COMPLAINT, MAGSTIM TECHNICAL SUPPORT HELD A CALL WITH THE CUSTOMER TO BEGIN PRELIMINARY INVESTIGATION INTO THE FAULT, THIS PRELIMINARY INVESTIGATION WAS SUFFICIENT TO DETERMINE THE CAUSE OF THE FAULT, THIS BEING THAT THE UNIT WAS CONFIGURED TO 240V VERSUS THE 120V REQUIREMENT FOR THE UNITED STATES. THE INCORRECT UNIT CONFIGURATION WAS THE CAUSE FOR THE DEVICE SYMPTOMS REPORTED. THE DEVICE IDENTIFIED IN THE COMPLAINT (S/N (B)(4)) WAS SENT FROM MAGSTIM LTD TO TECHNOMED EUROPE (INTERNATIONAL DISTRIBUTOR) BASED IN THE NETHERLANDS. ORDER INCLUDED MULTIPLE PLUG VARIANTS HOWEVER NO OTHER FUSES WERE SUPPLIED OTHER THAN THOSE INSTALLED ON DISPATCH (CONFIGURED TO 240V). ROOT CAUSE: S/N (B)(4) WAS SHIPPED FROM TECHNOMED EUROPE TO THE US CUSTOMER. THERE WAS NOT AN AWARENESS BY TECHNOMED EUROPE THAT THE VOLTAGE ON THE UNIT NEEDED TO BE CHANGED PRIOR TO DISPATCH. THE INITIAL ROOT CAUSE ASSESSMENT AND THIS DEFICIENCY IS CONSIDERED TO BE AN ABSENCE OF PROCESS FOR CONFIGURING THE UNIT BEFORE DISPATCH AT TECHNOMED EUROPE AND POTENTIALLY ABSENCE OF PROCESS FOR SHIPPING FUSES AT MAGSTIM. A FIELD CORRECTION (8021774-12182020-C - FCA-2020-03) HAS BEEN EXECUTED FOLLOWING THE RECEIPT OF THIS COMPLAINT AND A CAPA (CAPA 261) HAS BEEN INITIATED TO ADDRESS THE ABSENCE OF PROCESS.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED (FROM THE UNITED STATES) WAS REGARDING A BRAND NEW N100, WHERE THE COMPLAINANT REPORTED THAT THE BAR GRAPHS ON THE DEVICE DID NOT LIGHT UP AND THE DEVICE OVERALL WAS NOT WORKING. THERE WAS NO PATIENT HARM DURING THE EVENT. PRELIMINARY INVESTIGATION IDENTIFIED THAT THE CAUSE OF THE ERROR WAS THAT THE UNIT HAD BEEN CONFIGURED TO 240V (EUROPEAN CONFIGURATION) VERSUS THE 120V CONFIGURATION REQUIREMENT FOR THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72201 NEUROSIGN NEUROSIGN 100 ETN THE MAGSTIM COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1