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

Model Number	9513
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Increased Level of Consciousness (4590)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient 5/5: the customer has reported there has been several complaints of the device not recording correctly."also, sedline displaying erroneous psi readings, such as very low psi values despite the patient being awake and able to open their eyes.This has occurred on numerous occasions, and the devices have demonstrated significant inconsistency in their readings.Also, psi values remaining fixed at 25 for a prolonged period despite substantial changes in both surgical stimulation and the level of anaesthesia administered".
Additional Manufacturer Narrative
Other, 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 zip code exceeded allowable field length, initial reporter zip code is as follows: m20 4bx.E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).

• Brand Name: SEDLINE
• 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 ; 9492977167
• MDR Report Key: 25713404
• Report Number: 3019388613-2026-00382
• Device Sequence Number: 10619010
• Product Code: OLW
• UDI-Device Identifier: 00843997009096
• UDI-Public: (01)00843997009096
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• 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