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

Model Number	PMB4000-CE
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
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 during use of the monitor, the value was reported as inaccurate, with a high reading of 73.Concerns were raised that elevated index values were occurring more frequently on the advance monitor.No error messages appeared on the monitor.The user determined the value was incorrect based on observation of the patient, review of minimum alveolar concentration (mac), and review of anaesthetic delivery.It was unknown if there was any patient complications as a result of the event.

• Brand Name: BIS
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; 528604 52860 4; SN 528604
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; 528604 52860 4; SN 528604
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22333896
• Report Number: 2936999-2025-00350
• Device Sequence Number: 12994478
• Product Code: OLW
• UDI-Device Identifier: 10884521808270
• UDI-Public: 10884521808270
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPTED
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: PMB4000-CE
• Device Catalogue Number: PMB4000-CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/26/2025
• 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
• Patient Sex: Female