MAUDE Adverse Event Report: RENISHAW MAYFIELD SARL NEUROMATE GEN III

Model Number	NEUROMATE GEN III
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue has been resolved and a remind was done to the field service engineer.
Event or Problem Description
The planning station of the neuromate at (b)(6) hospital in (b)(6) was upgraded to (b)(6) via hard drive replacement.The first case to use the new upgraded system was delayed while the patient was in room and under anaesthesia because the neuromate could not establish a communication with neuroinspire when attempting to open the neuromate module.Over the phone with the field service engineer, the surgeon was directed to the appropriate configuration file for neuroinpire in order to update the com port to the correct port.The surgery was delayed of 1 hour.

• Brand Name: NEUROMATE GEN III
• Common Device Name: NEUROMATE GEN III
• Manufacturer (Section D): RENISHAW MAYFIELD SARL; 31, rue ampère; chassieu, rhone 69680 ; FR 69680
• MDR Report Key: 12467468
• Report Number: 3009108888-2021-00001
• Device Sequence Number: 20037587
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: NEUROMATE GEN III
• Device Catalogue Number: V1.5 (GEN III)
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1