MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM; GUIDELINE 5

Model Number	GUIDELINE 4000 LP+
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hospital was using fhc's microelectrode recording (mer) system along with our electrode and insertion tubes.The customer was recording when the mer system had a space issue in the memory of the laptop due to windows updates, which caused the user to get an error message regarding 'insufficient memory', while trying to delete some of the files (to free up memory) and rebooting the software, the patient had a seizure.The case was canceled.Later that day, the customer performed functionality testing on the subject product where no anomalies were found.The product was not returned to fhc for evaluation and is still in use at the hospital without issue.
Additional Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTEM
• Common Device Name: GUIDELINE 5
• Manufacturer (Section D): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: ms. moeykens ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 19670525
• Report Number: 3002250546-2024-00002
• Device Sequence Number: 3212436
• Product Code: GZL
• UDI-Device Identifier: 00873263002711
• UDI-Public: 00873263002711
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GUIDELINE 4000 LP+
• Device Catalogue Number: MT-LPP
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose