MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY DC-I; LNCS; OXIMETER

Model Number	1863
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a "patient's spo2 was reading 100% with a good pleth however observed that the patient didn't look good.They drew an arterial blood gas.The arterial blood gas reported spo2 83 with a pao2 of 48".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 sensor.The customer confirmed the sensor cannot be returned to masimo to allow an analysis to be performed as the sensor was misplaced.If the sensor is found and returned for evaluation or new information is obtained, a follow up report will be submitted.The customer was unable to provide the lot number for the sensor.As such, only the primary di number for the sensor could be obtained for the udi.H3 other text: product not returned.

• Brand Name: DC-I; LNCS
• Common Device Name: OXIMETER
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 23528720
• Report Number: 3019388613-2025-00151
• Device Sequence Number: 10186792
• Product Code: DQA
• UDI-Device Identifier: 00843997000406
• UDI-Public: (01)00843997000406
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051212
• 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
• Report Date (Section B): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1863
• Device Catalogue Number: 1863
• Was Device Available for Evaluation?: No
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native