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

Model Number	9513
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Increased Level of Consciousness (4590)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was a recent case of a patient experiencing awareness under ga, with sedline range reporting <45.It was an emergency case under tiva.A long case.Patient was stable.Towards the end of the case, about 30mins before end, anesthetist switched from propofol to sevoflurane, which was their usual practice.Patient later reported that they felt all of the suturing.Psi reported to always be below 45.
Additional Manufacturer Narrative
Other, other text: the module was reported not to be available for return.If the module is returned for evaluation or new information is obtained, a follow up report will be submitted.Additional module identifiers were not provided by the customer.

• 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: 24710065
• Report Number: 3019388613-2026-00107
• Device Sequence Number: 17558976
• Product Code: GWQ
• UDI-Device Identifier: 00843997009096
• UDI-Public: (01)00843997009096
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9513
• 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: 03/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PN 9515 ROOT, PN 4248 SENSOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown