BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 11115734 · Received January 5, 2021

    Report

    Report Number
    8021774-2021-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    November 5, 2020
    Report Date
    January 4, 2021
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    ETN
    PMA / PMN Number
    K053141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL FINDINGS - ON ARRIVAL N800 SN (B)(4) WENT THROUGH A FUNCTIONAL CHECK WHICH PICKED UP THE SAME FAULT THAT WAS DESCRIBED BY THE CUSTOMER; NO STIMULATION CURRENT SHOWING WHILE TESTING. INVESTIGATION NOTES - THE P/N1340-01 FRONT BEZEL WAS REMOVED TO FIND THAT THE BLUE AND WHITE WIRES HAS SNAPPED FROM THE P/N211418 4-WAY LEMO SOCKET. REPAIR NOTES - THE BLUE AND WHITE WIRES WERE RE-SOLDERED AND HEATSHRINK APPLIED IN ACCORDANCE WITH 1340-01 DRAWINGS. TEST NOTES - N800 REPAIRED AND TESTED TO THE ORIGINAL SPECIFICATIONS. ROOT CAUSE - A FINAL ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER FAILURE OF THE BLUE AND WHITE WIRES MAY HAVE BEEN CAUSED DURING THE TRANSPORTATION BACK TO THE CUSTOMER AS THE DEVICE PASSED ALL TESTING AFTER ITS INITIAL SERVICING. THIS FAILURE MODE WILL BE MONITORED FOR TREND PURPOSES. THE DEVICE WAS REPAIRED AND RETURNED TO THE END USER. NO FURTHER REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTATIVE ACTION OR FIELD SAFETY CORRECTIVE ACTION IS NECESSARY. ADDITIONAL NARRATIVE: EFFECTIVE 31ST DECEMBER 2018, THE NEUROSIGN 800 WAS DISCONTINUED. MAGSTIM CONTINUES TO OFFER SERVICE AND PREVENTATIVE MAINTENANCE FOR THE NEUROSIGN 800, HOWEVER, ANY PARTS REQUIRED DURING SERVICE AND PREVENTATIVE MAINTENANCE WILL BE SUBJECT TO AVAILABILITY.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED (FROM THE (B)(6)) WAS REGARDING A NEUROSIGN 800, THAT HAD BEEN RETURNED FOR SERVICE FOR AN ANNUAL SERVICE AND ON RETURN TO THE CUSTOMER FOUND TO BE DEFECTIVE WHERE THERE WAS NO STIMULATION/RESPONSE FROM THE UNIT. THE FAULT WAS DISCOVERED DURING SURGERY, A REPLACEMENT NERVE MONITOR WAS BROUGHT INTO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AND THERE WAS NO INTERNAL INVESTIGATION AT THE HOSPITAL. INVESTIGATION INTO THIS DEFECT IDENTIFIED THAT ONCE THE P/N1340-01 FRONT BEZEL WAS REMOVED, THE BLUE AND WHITE WIRES THAT ARE CONNECTED TO THE P/N211418 4-WAY LEMO SOCKET, HAD SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17564 NEUROSIGN NEUROSIGN 800 ETN THE MAGSTIM COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1