MAUDE Adverse Event Report: Covidien llc BIS; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number	186-1046
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(800)646-4633
• MDR Report Key: 50926550
• Report Number: 2936999-2026-00407
• Device Sequence Number: 13451744
• Product Code: OLW
• UDI-Device Identifier: 10884521129511
• UDI-Public: (01)10884521129511(11)140711
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K072286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 186-1046
• Device Catalogue Number: 186-1046
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 09/18/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male