MAUDE Adverse Event Report: COVIDIEN BIS; ELECTRODE, CUTANEOUS

Model Number	186-0106
Medical Device Problem Codes	Device Alarm System (1012); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
186-0106 186-0106 quatro sensor x25 0912241j 186-0106 186-0106 quatro sensor x25 0714241k 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 sensors experienced issues intraoperatively: the strip stopped working and the device indicated the need for replacement, the monitoring was not consistent with the clinical parameters observed with possibly incorrect values shown on the monitor, and there was no audible alarm.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no visible damage on the sensor.The smart chip was checked with a lot code tester where it was properly recognized and displayed the lot code 0714241k.The sensor was rehydrated using a pipette to place one drop of water on each electrode before adhering the sensor electrodes to a paperclip.The sensor was then connected to a test monitor where all but electrode 4 were able to pass the sensor check consistently.More details displayed by the monitor showed that electrode 4 was receiving significant noise.It was reported that the sensor experienced issues intraoperatively: the strip stopped working and the device indicated the need for replacement, the monitoring was not consistent with the clinical parameters observed with possibly incorrect values shown on the monitor, and there was no audible alarm.The reported issue 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.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23858430
• Report Number: 2936999-2025-00597
• Device Sequence Number: 10143772
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: (01)20884521134307(17)260114(10)0714241K(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 Expiration Date: 01/14/2026
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0714241K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 12/20/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11.
• Patient Sex: Unknown