MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy; Oximeter, Tissue Saturation

Model Number	3756
Medical Device Problem Codes	Defective Alarm (1014); Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they did not receive accurate o3 readings during the procedure, and no error message was displayed.The readings froze after approximately 60 minutes of monitoring.The customer unplugged and reconnected the sensors, after which they resumed measuring correctly.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the customer confirmed that the sensor will not be returned to masimo for an analysis to be performed.No sensor lot number was reported; therefore the sensor's full udi and manufacturing information could not be obtained.Health effect impact code: no adverse event; no patient impact.

• Common Device Name: Oximeter, Tissue Saturation
• 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: 50535906
• Report Number: 3019388613-2026-00583
• Device Sequence Number: 20324211
• Product Code: MUD
• UDI-Device Identifier: 10843997008416
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K214072
• 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
• Report Date (Section B): 08/06/2026

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: 3756
• Was Device Available for Evaluation?: No
• 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: 08/06/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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