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

Model Number	9513
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Increased Level of Consciousness (4590)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
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 the maximum allowable characters; zip code is as follows: (b)(6).E1.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: +(b)(6).
Event or Problem Description
The customer reported that in between surgery "when the psi was 21, [the] patient gained consciousness and all of a sudden 'self-extubated himself' and started moving while psi was still 20".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned module was evaluated.During evaluation the module passed all visual and functional testing.The module was found to provide no errors or interruptions to measurements during testing.The module was confirmed to be functioning as designed.The concomitant rd sedline cable was reported as lot 24m10; the cable received was identified as lot a25bd69.E1: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).E1: initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported that in between surgery "when the psi was 21, [the] patient gained consciousness and all of a sudden 'self-extubated himself' and started moving while psi was still 20".There was no patient impact or consequence reported.

• 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 23354151
• Report Number: 3019388613-2025-00128
• Device Sequence Number: 8871942
• Product Code: OLW
• UDI-Device Identifier: 00843997009096
• UDI-Public: (01)00843997009096(11)250404
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/23/2025

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: 9513
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RDSEDLINE CABLE LOT 24M10 ROOT SN (B)(6); SEDLINE CBL A25BD69 ROOT SN (B)(6)
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 55 KG