MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy Sedline Seditation Monitor; Electroencephalograph

Model Number	9513
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Increased Level of Consciousness (4590)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported "sedline plug-in module indicating that a patient experienced anesthesia awareness during surgery.The anesthesiologist indicated the psi of the sedline module was at 20 but further information was not available.The patient was discharged from the monitor, which was not connected to a central station." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: 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.

• Brand Name: Sedline Seditation Monitor
• 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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; +1(949)297-7167
• MDR Report Key: 50878075
• Report Number: 3019388613-2026-00690
• Device Sequence Number: 9223835
• Product Code: OLW
• UDI-Device Identifier: 00843997009096
• UDI-Public: (01)00843997009096
• 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: Other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 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: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sex: Unknown