MAUDE Adverse Event Report: COVIDIEN BIS; ELECTRODE, CUTANEOUS

Model Number	186-0200
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, the bis value was displayed as 0.There was no reported patient outcome.
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.
Additional Manufacturer Narrative
Additional information: b5, d4 (expiration date, lot#), d9, g3, h3, h4, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the sensor was connected to the bis vista monitor where none of its electrodes were able to pass the initial impedance check.It was reported that the bis reported low readings.The reported issue was confirmed.The most likely cause was traced to component failure.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
According to the reporter during use, the bis value was displayed as 0 at the stage when it was was not under anesthesia.There was no reported patient outcome.

• Brand Name: BIS
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20912975
• Report Number: 2936999-2024-01832
• Device Sequence Number: 7824804
• Product Code: GXY
• UDI-Device Identifier: 10884521134331
• UDI-Public: 10884521134331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2025

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 Expiration Date: 03/23/2025
• Device Model Number: 186-0200
• Device Catalogue Number: 186-0200
• Device Lot Number: 0923231L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown