MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY SEDLINE MODULE; ELECTROENCEPHALOGRAPH

Model Number	9829
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during cardiac surgery, "the root/sedline system indicated insufficient sedation for a period of approximately 20 minutes.The patient was therefore given deeper sedation.After this period of anesthesia, the data no longer appeared to be plausible".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.E1.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).H3 other text: product not returned.

• Brand Name: SEDLINE MODULE
• Common Device Name: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24374021
• Report Number: 3019388613-2026-00049
• Device Sequence Number: 14661893
• Product Code: OLW
• UDI-Device Identifier: 00843997012898
• UDI-Public: (01)00843997012898(11)200818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 9829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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: MASIMO ROOT PN 9695, SN. (B)(6)
• Patient Sex: Unknown