MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP SENSOR; OXIMETER

Model Number	4050
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: device evaluation is anticipated.When the device is evaluated or 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 the sensor "spo2 measurement stable at 93% in copd patient, and concomitant measurement sao2 at 84.4% (differential >8%)." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned sensor and concomitant cable were evaluated.The sensor and cable passed visual inspection and continuity testing.Spo2 and pulse rate measurements were obtained when functionally tested with a lab drager infinity m540 monitor.No product performance issues related to spo2 measurements were identified.The sensor and cable were determined to be functioning as designed.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the sensor "spo2 measurement stable at 93% in copd patient, and concomitant measurement sao2 at 84.4% (differential >8%)." there was no patient impact or consequence reported.

• Brand Name: RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP SENSOR
• 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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; 9492977167
• MDR Report Key: 24601474
• Report Number: 3019388613-2026-00092
• Device Sequence Number: 8384392
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)251007(10)25KDC
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K180046
• 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,Followup
• Report Date (Section B): 02/19/2026

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: 4050
• Device Lot Number: 25KDC
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/27/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 05/05/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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: MD20-12 CABLE (LOT 25HNU)
• Patient Sex: Female