MAUDE Adverse Event Report: COVIDIEN LLC BIS; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number	PMB4000DOC
Medical Device Problem Codes	Failure to Run on Battery (1466); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: concomittant product: pmb4000-ce-bis advance monitor-j772520054 pmb4000doc-bis advance docking station-jdc2527467 186-0224-ams- aspect bis x4 cm x1-b449746 pmb4000pws-bis adv monitor power supply-unknown.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that prior to use, the monitor and docking station would not charge, but upon inspection, it was found that the bottom of the docking station where the charger was connected burnt.No smoke was seen.There was no patient involvement.

• Brand Name: BIS
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer (Section G): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25523251
• Report Number: 2936999-2026-00227
• Device Sequence Number: 10627166
• Product Code: OLW
• UDI-Device Identifier: 10884521808300
• UDI-Public: (01)10884521808300(11)250707
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/16/2026

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 Model Number: PMB4000DOC
• Device Catalogue Number: PMB4000DOC
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 07/07/2025
• 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 NOTE ON H11.
• Patient Sex: Unknown