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

Model Number	186-0195-GE
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Temperature Problem (3022); Material Split, Cut or Torn (4008)
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 during servicing, a host cable was damaged, the pic cable had a gouge and did not meet cosmetic criteria, the clamp was broken, the bulkhead was corroded, and the protective shield was burnt.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Correction: b5 (event description).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the board was in good condition.Functionally, the device was tested and passed all tests.The issue was resolved by replacing all listed components.It was reported that the host cable was damaged, and the patient interface cable had a gouge and did not meet cosmetic criteria, the clamp was broken, the bulkhead was corroded, and the protective shield was burnt.The reported issues were confirmed.The most likely cause was 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.
Event or Problem Description
It was reported that during servicing, a host cable was damaged, the patient interface cable had a gouge and did not meet cosmetic criteria, the clamp was broken, the bulkhead was corroded, and the protective shield was burnt.

• 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: 22661013
• Report Number: 2936999-2025-00398
• Device Sequence Number: 14381580
• Product Code: OLW
• UDI-Device Identifier: 10884521129665
• UDI-Public: 10884521129665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 186-0195-GE
• Device Catalogue Number: 186-0195-GE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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