MAUDE Adverse Event Report: COVIDIEN BIS; ELECTRODE, CUTANEOUS

Model Number	186-0200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/15/2025
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 a pediatric patient in the intensive care unit had pressure ulcers from the sensor.The patient, who was paralyzed, had the sensor applied to the forehead after the area was cleaned with an alcohol wipe.The sensor was used from 8 pm on (b)(6), 2025, until 10 am on (b)(6) 2025.Upon removal, red sores and scabs were observed on the patient's forehead, indicating that the sensor had broken the skin and caused a pressure ulcer.The patient did not have any preexisting skin conditions or known allergies, and the sensor was used according to the instructions for use and protocol.The skin integrity issue persisted for three weeks.
Event or Problem Description
It was reported that a pediatric patient in the intensive care unit who was paralyzed had the sensor applied to the forehead after the area was cleaned with an alcohol wipe.The sensor was used for 14 hours and upon removal, red sores and scabs were observed on the patient's forehead, indicating that the sensor broke the skin and caused a pressure ulcer which persisted for three weeks.There was no specific treatment but it was left open to air and patient recovered.The patient did not have any preexisting skin conditions or known allergies, and the sensor was used according to the instructions for use and protocol.
Additional Manufacturer Narrative
Correction: b5 additional information: d9, g3, g6, h6 device evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors and the sample met all related specifications.It was reported that a pediatric patient in the intensive care unit who was paralyzed had the sensor applied to the forehead after the area was cleaned with an alcohol wipe.The sensor was used for 14 hours and upon removal, red sores and scabs were observed on the patient's forehead, indicating that the sensor broke the skin and caused a pressure ulcer.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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
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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21309187
• Report Number: 2936999-2025-00051
• Device Sequence Number: 8076101
• Product Code: GXY
• UDI-Device Identifier: 10884521134331
• UDI-Public: (01)10884521134331(17)250314(10)0914231L(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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: 03/14/2025
• Device Model Number: 186-0200
• Device Catalogue Number: 186-0200
• Device Lot Number: 0914231L
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 12/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 09/24/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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