MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD BIS; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number	186-0195-AMS
Medical Device Problem Codes	Use of Device Problem (1670); Low Readings (2460)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 186-1046 186-1046 intl vista bis monitor w accy serial number: (b)(6).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 eeg reading was 30-50 throughout the procedure but the patient suddenly moved, sat up then lay back down which occurred within 15 seconds.The anesthetic team managed the situation promptly.There was no reported patient outcome.

• Brand Name: BIS
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21375039
• Report Number: 2936999-2025-00058
• Device Sequence Number: 19776072
• Product Code: OLW
• UDI-Device Identifier: 10884521129832
• UDI-Public: 10884521129832
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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-AMS
• Device Catalogue Number: 186-0195-AMS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES IN H11
• Patient Sex: Unknown