MAUDE Adverse Event Report: THE MAGSTIM COMPANY LIMITED NEUROSIGN; NEUROSIGN V4 - STIMULATOR POD

Model Number 4440-00

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: NEUROSIGN
• Type of Device: NEUROSIGN V4 - STIMULATOR POD
• Manufacturer (Section D): THE MAGSTIM COMPANY LIMITED; spring gardens; whitland; carmarthenshire SA340 HR; UK SA340HR
• Manufacturer (Section G): THE MAGSTIM COMPANY LIMITED; spring gardens; whitland; carmarthenshire SA340 HR; UK SA340HR
• Manufacturer Contact: tom campbell ; spring gardens; whitland; carmarthenshire SA340-HR ; UK SA340HR
• MDR Report Key: 11670048
• MDR Text Key: 248005257
• Report Number: 8021774-2021-00004
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 05060229531865
• UDI-Public: 05060229531865
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K203684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4440-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other