MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SEDLINE; 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	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.At the conclusion of the investigation or if new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported during anesthesia, values indicative of an awake state were observed.After replacing the consumable, readings returned to levels consistent with anesthesia.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned sensor was evaluated.The sensor was found to have an open trace at the tip of the connector.Accuracy testing was not able to be conducted since the sensor was returned as used.The reported issue could not be confirmed through testing.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported during anesthesia, values indicative of an awake state were observed.After replacing the consumable, readings returned to levels consistent with anesthesia.There was no patient impact or consequence reported.

• Brand Name: RD 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24541183
• Report Number: 3019388613-2026-00079
• Device Sequence Number: 9158014
• Product Code: OLW
• UDI-Device Identifier: 10843997011775
• UDI-Public: (01)10843997011775(17)270401(10)E25HMG
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: E25HMG
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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