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

Model Number	186-1046
Medical Device Problem Codes	Device Alarm System (1012); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing and demo, the monitor did not measure correctly.There were no errors messages, audio and visual alarms.There was no patient involvement.
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.

• 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: 23785717
• Report Number: 2936999-2025-00583
• Device Sequence Number: 5712609
• Product Code: OLW
• UDI-Device Identifier: 10884521129511
• UDI-Public: (01)10884521129511(17)500101
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 186-1046
• Device Catalogue Number: 186-1046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 11/03/2011
• 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