MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number	186-0106
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the literature, the sensor caused a reversible skin lesion in the patient undergoing surgery.The electrodes were applied, the patient was positioned, and pressure areas were carefully padded and used for monitoring during this uneventful 2.5-hour procedure.After removing the electrodes, well-defined, erythematous markings were observed on the skin, corresponding to the electrode placement sites.These markings were classified as non-blistering, non-urticarial, and blanching; there were no other signs of a systematic allergic reaction.The marks were not typical of allergic contact dermatitis but more likely due to an irritant and the pressure effect of the monitor.A follow-up visit three weeks later revealed the near disappearance of the marks. .
Additional Manufacturer Narrative
Contact dermatitis with the bispectral index, ¿ quarto covidien sensor, authors: s.Swami, s.Harte, and k.Fitzgerald, ir med j; february 2024; vol 117; no.2; p921 22nd february, 2024.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): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer (Section G): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19367215
• Report Number: 2936999-2024-00798
• Device Sequence Number: 12348075
• Product Code: GXY
• UDI-Device Identifier: 90884521657515
• UDI-Public: 90884521657515
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: 05/15/2014
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/21/2024
• 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 Age: 15 YR
• Patient Sex: Male