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

Model Number	4248
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: device evaluation is anticipated.At the conclusion of our investigation or if new information is obtained, a follow-up report will be submitted.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).
Event or Problem Description
The customer reported that during anesthesia, values indicative of an awake state were observed.After replacement of the disposable components, values consistent with anesthesia were observed.There was no patient impact or consequence reported.
Event or Problem Description
The customer reported that during anesthesia, values indicative of an awake state were observed.After replacement of the disposable components, values consistent with anesthesia were observed.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.The sensor was found to have an open trace at the tip of the sensor connector.The returned sensor was used; therefore, accuracy testing could not be performed.The reported issue could not be replicated during testing.B3.Corrected "event date" from 01/01/1901 to 01/01/2026.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).

• Brand Name: SEDLINE EEG SENSOR
• 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: 24423684
• Report Number: 3019388613-2026-00057
• Device Sequence Number: 12247079
• Product Code: OLW
• UDI-Device Identifier: 10843997011775
• UDI-Public: (01)10843997011775(17)261202(10)25F03
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 01/29/2026

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: 4248
• Device Lot Number: 25F03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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