BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 14944298 · Received July 7, 2022

    Report

    Report Number
    8021774-2021-00015
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    August 26, 2021
    Report Date
    January 28, 2022
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    ETN
    PMA / PMN Number
    K203684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A MAGSTIM REPRESENTATIVE WENT IN TO TEST SYSTEM AND RETRIEVE SYSTEM LOG, WHILE THEY COULD NOT RECREATE THE ISSUE, AS THE SOUND WAS WORKING FINE ON THE DEVICE. IT WAS SUSPECTED THERE COULD BE AN ISSUE WITH WITH THE MUTE SENSOR. ON THE (B)(6) 2021 A REPLACEMENT V4 MUTE SENSOR (4225-00 SN:0113) WAS SENT OUT TO THE USER. ON THE (B)(6) 2021 THE SUSPECTED FAULTY MUTE SENSOR (SN:0043) WAS RETURNED AND PASSED FUNCTIONAL AND THE FULL TEST (TEST METHOD 4225-00 V4 MUTE SENSOR FUNCTIONAL TEST METHOD REV 1.0). THE NEXT STEP OF THE INVESTIGATION IS TO HAVE A MAGSTIM REPRESENTATIVE ATTEND THE SITE AND WITNESS THE DEVICE IN USE TO ESTABLISH THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    A MAGSTIM REPRESENTATIVE WENT IN TO TEST SYSTEM AND RETRIEVE SYSTEM LOG, WHILE THEY COULD NOT RECREATE THE ISSUE, AS THE SOUND WAS WORKING FINE ON THE DEVICE. IT WAS SUSPECTED THERE COULD BE AN ISSUE WITH THE MUTE SENSOR ON THE 10/09/2021 A REPLACEMENT V4 MUTE SENSOR (B)(6) WAS SENT OUT TO THE USER. ON THE 29/09/2021 THE SUSPECTED FAULTY MUTE SENSOR (B)(6) WAS RETURNED AND PASSED FUNCTIONAL AND THE FULL TEST (TEST METHOD 4225-00 V4 MUTE SENSOR FUNCTIONAL TEST METHOD REV 1.0) THE NEXT STEP OF THE INVESTIGATION IS TO HAVE A MAGSTIM REPRESENTATIVE ATTEND THE SITE AND WITNESS THE DEVICE IN USE TO ESTABLISH THE ROOT CAUSE. THERE ARE CURRENTLY PREVENTATIVE CONTROL MEASURES FOR HAZ ID: 186 IN TD4230034_13 - V4 RISK MANAGEMENT REPORT, THESE ARE : WHILE THE DEVICE WAS AUDIBLY MUTED, THE SYSTEM PROVIDES AN VISUAL REPRESENTATION OF THE EMG RESPONSES AS WELL AS A AUDIO REPRESENTATION. DURING INITIAL SET UP THE SYSTEM IS FUNCTIONALITY TESTED IN SYSTEM VERIFICATION PROCEDURE TD4230014 AND RESULTS TABLES TD4230021, SECTION 3.5. THIS INDICATES TO THE CUSTOMER THAT THE DEVICE IS STILL WORKING JUST THAT THE AUDIO ISN'T FUNCTIONING WHICH WHILE A FAULT/ERROR, IS NOT A SAFETY ISSUE THAT WOULD NOT LEAD TO A HEALTH IMPACT TO THE PATIENT. AFTER A PHONE CALL BETWEEN THE CUSTOMER AND A MAGSTIM REPRESENTATIVE IT WAS MENTIONED THAT THE CUSTOMER IS USING A MUTE SENSOR WHEN THEY ARE NOT PREFORMING ELECTROCAUTERY, THIS IS NOT RECOMMENDED AS STATED IN THE MANUAL NOP08-EN UNDER SECTION 2.3 MUTE SENSOR. "IF MONOPOLAR ELECTROCAUTERY IS USED THE MUTE SENSOR SHOULD BE ATTACHED TO THE ACTIVE LEAD OF THE ELECTROCAUTERY MACHINE. IF ONLY BIPOLAR ELECTROCAUTERY IS USED, THE MUTE SENSOR IS NOT NECESSARY. DO NOT CONNECT THE MUTE SENSOR IF IT IS NOT TO BE USED. NOTE: DO NOT CONNECT THE MUTE SENSOR TO THE NERVE MONITOR WITHOUT ATTACHING THE CLAMP TO THE ELECTROCAUTERY CABLE OR SPURIOUS MUTING OF THE NERVE MONITOR MAY OCCUR.". THIS WOULD CAUSE UNINTENTIONAL MUTING AS SEE WITH THIS SITUATION, WHERE THEY WERE NOT USING MONOPOLAR ELECTROCAUTERY, SO THEY WERE ATTACHING THE MUTE SENSOR UNNECESSARILY LEADING TO THE MUTING. THE SAME ERROR WAS IDENTIFIED WHEN THE CUSTOMER ATTEMPTED TO USE ANOTHER DEVICE OF THE SAME MODEL THEY ALREADY OWNED (B)(6) AND WITNESSED THE SAME ERROR WHICH RECONFIRMED THE FAULT WAS DOWN TO USER ERROR. THE RISK ASSESSMENT WAS DETERMINED TO STILL BE ADEQUATE DUE TO THE FACT THAT A SIMILER FAULT IS CONSIDERED UNDER HAZ ID: 186 IN THE TD4230034_13 - V4 RISK MANAGEMENT REPORT.

    Description of Event or Problem · 0

    ON THE (B)(6) 2021 IT WAS REPORTED THAT THE SYSTEM WAS MUTING DURING SURGERY WHEN IT WASN'T EXPECTED TOO. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    ON THE 01/09/2021 IT WAS REPORTED THAT THE SYSTEM WAS MUTING DURING SURGERY WHEN IT WASN'T EXPECTED TOO. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722855 NEUROSIGN NEUROSIGN V4 ETN THE MAGSTIM COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown