MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED CORTICAL STIMULATOR CONTROL UNIT-FIXED

Model Number	515-005500F
Medical Device Problem Codes	Computer Software Problem (1112); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part 515-005500f - error message regarding dsm control issue/internet during emu monitoring.Procedure at the time was surgical eeg placement and emu admission.
Additional Manufacturer Narrative
Initial report ref natus complaint (b)(4).Per (b)(4) rev 21 nicoletone eeg risk analysis spreadsheet hazard 5.19 - loose or unreliable or improper connection to stimulators or amplifier results in disruption to data collection.Effect (harm): delayed diagnosis - with no clinical effects.The hazards identified have rba rating of negligible and are deemed broadly acceptable.These risks have been reviewed to determine if any further control measures may be implemented so as to further reduce the risk as far as possible.Risk outweighed by benefit of use of device.No related capas.17-mar-2025: per returned adverse event questionnaire the follwoing was documented: during cortical stimulation on eeg, the eeg machine was initially connected to the internet.Then randomly at a certain time (not at beginning of stimulation session), it had an error message on screen (error hr=0x80004005).The doctor closed and opened dsm stimulation from control panel, but it had a different error message "failed to create relay control tool bar".Natus was notified right away.The doctor and eeg technician stopped the eeg recording, disconnected the internet cable and opened study of eeg on local machine.The problem was solved and cortical stimulation control on screen was working.The device was not returned, as the issue was resolved onsite.No further actions required.

• Brand Name: CORTICAL STIMULATOR CONTROL UNIT-FIXED
• Common Device Name: CORTICAL STIMULATOR CONTROL UNIT-FIXED
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; 3150 pleasant view road; middleton 53562
• MDR Report Key: 21662396
• Report Number: 3010611950-2025-00002
• Device Sequence Number: 15641291
• Product Code: ETN
• UDI-Device Identifier: 00382830041799
• UDI-Public: 00382830041799
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072964
• 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
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: 515-005500F
• Device Catalogue Number: 515-005500F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American