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

Model Number	4050
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.H3 - other text: product not returned.
Event or Problem Description
The customer reported, "under low-light conditions (bed headboard lamp), at approximately 5:00 pm, the pulse oximeter showing a good plethysmographic waveform and an adequate perfusion index indicated an spo2 of 99%.The patient had warm skin.The sensor was tested on several fingers of an unspecified hand.At the time of arterial blood gas analysis, the measured oxygen saturation was 78%.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was found to provide accurate measurements within specification.The sensor was confirmed to be functioning as designed.E1: initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported, "under low-light conditions (bed headboard lamp), at approximately 5:00 pm, the pulse oximeter showing a good plethysmographic waveform and an adequate perfusion index indicated an spo2 of 99%.The patient had warm skin.The sensor was tested on several fingers of an unspecified hand.At the time of arterial blood gas analysis, the measured oxygen saturation was 78%.There was no patient impact or consequence reported.

• Brand Name: RD SET DCI SPO2 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24274989
• Report Number: 3019388613-2026-00034
• Device Sequence Number: 21337648
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)240621(10)24FBZ
• 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
• Report Date (Section B): 01/12/2026

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: 24FBZ
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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: PHILIPS X3, MASIMO PN 4078 LOT 22HGS; PHILIPS X3, MASIMO PN 4078 LOT 22HGS
• Patient Age: 67 YR
• Patient Sex: Unknown