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

Model Number	186-1046
Medical Device Problem Codes	Device Alarm System (1012); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the monitor displayed hardware error message 2902 on device start-up during pre-operative preparation for use.The monitor did not alarm when the error occurred.Troubleshooting steps included rebooting the monitor.There was no patient involved.
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.Visual inspection noted found indentations on the power button.Display was observed to be dim.The module was found intermittently difficult to connect.The issue was resolved by removing of the power cord.Performed and again passed without issue.It was reported that the monitor did not alarm when the error occurred.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the monitor displayed hardware error message 2902 on device start-up the reported issue was confirmed.The most likely cause was component failure.Hypertronics connector found one of the pins slightly damaged, 2 battery housing standoffs broken, very slight signs of corrosion on the speaker connector pins, and the battery was found to at an age beyond expiration.The most likely cause for these additional conditions were traced to a component failure.The manufactur ing 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: 24218776
• Report Number: 2936999-2026-00039
• Device Sequence Number: 20977239
• Product Code: OLW
• UDI-Device Identifier: 10884521129511
• UDI-Public: (01)10884521129511(11)110327
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 186-1046
• Device Catalogue Number: 186-1046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2011
• 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