MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET; OXIMETER

Model Number	4052
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event, no patient impact, h3 other text: sensor not returned.
Event or Problem Description
The customer reported "the sensor stopped working when the patient was connected, but there was no breakage on the device.This type of sensor has a higher impedance, resulting in a saturation reading approximately 8-10 points lower than arterial blood gas analysis.This has been reported several times by my team.The perfusion signal is above 1, indicating a good signal and waveform"."the clinicians observed a significant discrepancy between the blood gas measurement and the spo2 measurement".The spo2 measurement from the sensor was 99% and the abg so2 measurement was 90%.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: based on additional information the following fields were corrected: section d.Suspect medical device, g.All manufacturers, and h.Device manufacturers only: d1.Brand name was lncs-ii rainbow; is rd set.D4.Model # was 4067; is 4052.D4.Lot # was ; is (b)(6).D4.Unique device identifier (udi) # was (b)(4).G4.Pma/510(k) # was k080238; is k180046.H4.Device manufacture date was ; is 11/24/2022 h3 other text: sensor not returned.
Event or Problem Description
The customer reported "the sensor stopped working when the patient was connected, but there was no breakage on the device.This type of sensor has a higher impedance, resulting in a saturation reading approximately 8-10 points lower than arterial blood gas analysis.This has been reported several times by my team.The perfusion signal is above 1, indicating a good signal and waveform." "the clinicians observed a significant discrepancy between the blood gas measurement and the spo2 measurement." the spo2 measurement from the sensor was 99% and the abg so2 measurement was 83.7%.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned sensor was evaluated.The sensor passed visual inspection and continuity testing.The sensor was able to obtain accurate readings continuously during functional testing.The sensor was 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 stopped working when the patient was connected, but there was no breakage on the device.This type of sensor has a higher impedance, resulting in a saturation reading approximately 8-10 points lower than arterial blood gas analysis.This has been reported several times by my team.The perfusion signal is above 1, indicating a good signal and waveform." "the clinicians observed a significant discrepancy between the blood gas measurement and the spo2 measurement." the spo2 measurement from the sensor was 99% and the abg so2 measurement was 83.7%.There was no patient impact or consequence reported.

• Brand Name: RD SET
• 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 ; 9492977862
• MDR Report Key: 23936813
• Report Number: 3019388613-2025-00188
• Device Sequence Number: 5610248
• Product Code: DQA
• UDI-Device Identifier: 00843997014298
• UDI-Public: (01)00843997014298(11)221124(10)22M5H
• 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): 12/05/2025

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: 4052
• Device Lot Number: 22M5H
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 03/03/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/30/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White