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

Model Number	4473
Medical Device Problem Codes	Unable to Obtain Readings (1516); Sensing Intermittently (1558); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the sensor stop(s) functioning (emitter light switch off), no alarm on "mindray monitor".Disconnect and reconnect the sensor didn't change the situation.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
The device was reported to be available for analysis.The device has not been received by masimo's investigation facility to allow for an analysis to be performed.When the device is received and the investigation is completed, 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.

• 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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; 9492977167
• MDR Report Key: 24710248
• Report Number: 3019388613-2026-00108
• Device Sequence Number: 14865939
• Product Code: DQA
• UDI-Device Identifier: 10843997013229
• UDI-Public: (01)10843997013229(17)280801(10)25HR3
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101896
• 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): 03/02/2026

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: 4473
• Device Lot Number: 25HR3
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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
• Patient Sex: Unknown