BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 11670048 · Received April 15, 2021

    Report

    Report Number
    8021774-2021-00004
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 11, 2021
    Report Date
    January 28, 2022
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    PDQ
    UDI-DI
    05060229531865
    PMA / PMN Number
    K203684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REMOTE INVESTIGATION INTO REPORTED FAULT PERFORMED AND WAS REPLICATED DURING INVESTIGATION. LOCAL SALES REPRESENTATIVE (ASF GESTION) DISCONNECTED AND RECONNECTED ALL ACCESSORIES BUT RESET DID NOT CORRECT FAULT. DEVICE RETURNED TO DISTRIBUTOR FOR FURTHER INVESTIGATION. DISTRIBUTOR CONFIRMED REPLACEMENT OF THE 4440-00 STIMULATOR POD WITH AN ALTERNATIVE UNIT CORRECTED THE FAULT. THIS SUGGESTED 4440-00 WAS THE ROOT CAUSE OF THE FAULT. THE 4440-00 V4 STIMULAR POD WAS RETURNED TO MAGSTIM FOR INVESTIGATION AND SERVICE (RMA 9823). DEVICE RETURNED TO MAGSTIM - INITIAL OBSERVATIONS CONFIRMED THE FAULT AS REPORTED IN THE COMPLAINT. DEVICE SUBJECT TO INVESTIGATORY TESTING TO IDENTIFY ROOT CAUSE. STIM POD PASSED INTERNAL TEST METHOD 4440-00-V1.0. HOWEVER FAULT WAS STILL PRESENT. ADDITIONAL TESTING PERFORMED BY MAGSTIM TO IDENTIFY ROOT CAUSE. INVESTIGATORY TESTING PERFORMED BY MAGSTIM IDENTIFIED ROOT CAUSE AS A SHORT CIRCUIT PRESENT IN THE L3 COMPONENT OF THE 4281 STIM POD PCB. NO OTHER SIMILAR FAULTS HAVE BEEN REPORTED FOR THIS DEVICE. THERE HAVE BEEN NO OTHER INCIDENCES OF THIS FAULT OCCURRING IN OTHER DEVICES. THE RISK ASSESSMENT HAS BEEN REVIEWED ((B)(4) AND THE HAZARDOUS SITUATION THAT IS PRESENT IN THIS OCCURRENCE IS NOT INCLUDED OR ADDRESSED AND THEREFORE THE RISK ASSESSMENT IS NOT CONSIDERED TO REMAIN ADEQUATE. A NEW HAZARD (253) WILL BE RAISED TO REPRESENT THIS POTENTIAL FAILURE MODE AND TO IDENTIFY AND VERIFY IF ANY RISK CONTROL MEASURES THAT WILL REDUCE ANY REMAINING RESIDUAL RISK.

    Description of Event or Problem · 0

    INITIAL REPORT IDENTIFIED THE "CURRENT CONFIRM" INDICATOR BEING ACTIVE ON THE NEUROSIGN V4 USER INTERFACE WHEN NO CURRENT WAS BEING APPLIED. ISSUE WAS IDENTIFIED BEFORE SURGERY AND ALTERNATIVE NEUROSIGN V4 DEVICE USED. NO HARM TO PATIENT OR USER RECORDED. NO SIGNIFICANT DELAY TO SURGERY REPORTED.

    Additional Manufacturer Narrative · 1

    AN INITIAL REMOTE INVESTIGATION WAS CONDUCTED BETWEEN MAGSTIM SERVICE AND THE DISTRIBUTOR ASF GESTION. THE REPORTED FAULT (CURRENT INDICATOR ALWAYS ON - GREEN ILLUMINATION OF THE STIMULATOR CURRENT SETTING) WAS WITNESSED FIRST IN THE OPERATING THEATRE AND REPEATED LATER OUTSIDE OF THE OPERATING THEATRE. THE SALES REPRESENTATIVE (ASF GESTION) DISCONNECTED AND RECONNECTED ALL ACCESSORIES, HOWEVER THIS DID NOT REMEDY THE FAULT. THE DEVICE WAS RETURNED TO THE DISTRIBUTOR HQ FOR FURTHER TROUBLE SHOOTING. DURING THIS EXERCISE, ASF CONFIRMED THAT REPLACING THE 4440-00 STIMULATOR POD WITH A ALTERNATIVE UNIT ADDRESSED THE FAULT SUGGESTING THE 4440-00 WAS THE CAUSE OF THE CONSTANTLY ILLUMINATED CURRENT CONFIRM. THE 4440-00 V4 STIMULATOR POD (SN 0010) WAS THEREFORE SUBSEQUENTLY RETURNED FOR SERVICE AND INVESTIGATION (RMA 9823). ON THE 30/03/2021 THE DEVICE WAS RECEIVED BY THE MANUFACTURER (MAGSTIM LTD - (B)(4)). INITIAL ASSESSMENT CONFIRMED THE COMPLAINT AS REPORTED BY THE DISTRIBUTOR. THE FAULTY DEVICE WAS SUBJECT TO ITS PRODUCTION TEST METHOD - TM4440-00-(B)(4), PASSING ALL TESTS. THE UNIT IS BEING SUBJECT TO FURTHER INVESTIGATION BY MAGSTIM R&D TO DETERMINE THE FAULT OF THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURRENT CONFIRM INDICATOR ON THE NEUROSIGN V4 USER INTERFACE WAS ACTIVE WHEN CURRENT WAS NOT BEING APPLIED. NOTE: THE PURPOSE OF THE CURRENT CONFIRM IS TO INDICATE TO THE USER THAT THE SET CURRENT/VOLTAGE HAS BEEN APPLIED. THIS ERROR WAS NOTICED AT THE BEGINNING OF THE SURGERY; AND SUBSEQUENTLY REPORTED BACK TO THE DISTRIBUTOR. THE DEVICE WAS REMOVED FROM THE SURGICAL ROOM AND A NEUROSIGN 400 (ALTERNATIVE DEVICE) USED IN REPLACEMENT. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568004 NEUROSIGN NEUROSIGN V4 - STIMULATOR POD PDQ THE MAGSTIM COMPANY LIMITED 4440-00 05060229531865

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other