MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy O3 Module; Oximeter

Model Number	9637
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the "module measured high".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the customer confirmed that the device will not be returned to masimo for an analysis to be performed. if the device is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.

• Brand Name: O3 Module
• 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 ; +1(949)297-7167
• MDR Report Key: 50927218
• Report Number: 3019388613-2026-00703
• Device Sequence Number: 9688782
• Product Code: DQA
• UDI-Device Identifier: 00843997010771
• UDI-Public: (01)00843997010771(11)250529
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K214072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: 9637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2025
• 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