MAUDE Adverse Event Report: COVIDIEN LLC BIS; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number	186-0195-AMS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during procedure, the monitor had a reading of 43, however, the patient experienced an episode of intraoperative awareness.Failure was isolated to the monitor.It was also reported that the module allegedly was used during the procedure, however it displayed a different serial number on the the monitor.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found no failure.It was reported that the monitor had a reading of 43, however, the patient experienced an episode of intraoperative awareness.It was also reported that the module allegedly was used during the procedure, however it displayed a different serial number on the the monitor.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of cosmetic damage to housing and damaged host cable gasket seal.The most likely cause for the additional condition is traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIS
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer (Section G): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25348616
• Report Number: 2936999-2026-00207
• Device Sequence Number: 18808667
• Product Code: OLW
• UDI-Device Identifier: 10884521129832
• UDI-Public: (01)10884521129832(11)221216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 186-0195-AMS
• Device Catalogue Number: 186-0195-AMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown