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

Model Number	4248
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient remained awake while the psi values continuously stayed between 18 and 25.The sensor was attached before induction, and all impedance indicators were green.Even though induction had not yet started, the psi value dropped from 100 to 25.During this time, the patient's eyes were open.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
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 phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.H3 other text: product not returned.
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.The sensor passed all visual and continuity testing.As the sensor was used, accuracy testing could not be performed.The reported psi inaccuracy could not be confirmed through testing.E1: initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported that the patient remained awake while the psi values continuously stayed between 18 and 25.The sensor was attached before induction, and all impedance indicators were green.Even though induction had not yet started, the psi value dropped from 100 to 25.During this time, the patient's eyes were open.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 ; 9492977862
• MDR Report Key: 23723599
• Report Number: 3019388613-2025-00166
• Device Sequence Number: 18823100
• Product Code: OLW
• UDI-Device Identifier: 10843997011775
• UDI-Public: (01)10843997011775(17)270101(10)E25GWA
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: E25GWA
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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