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

Model Number	1864
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the sensor "spo2 measurements were inaccurate (o2 percentage variance > 3)." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the sensor.The sensor 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.Due to the product lot being manufactured in 2012, the manufacturing date could not be obtained and therefore a full udi could not be determined.Health effect impact code: no adverse event; no patient impact h3 other text : device not returned.

• Brand Name: LNCS DCI
• 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24515725
• Report Number: 3019388613-2026-00074
• Device Sequence Number: 15584276
• Product Code: DQA
• UDI-Device Identifier: 00843997000413
• UDI-Public: (01)00843997000413
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 1864
• Device Catalogue Number: 1864
• Device Lot Number: 2H166
• 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: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• 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
• Patient Sex: Unknown