MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY DCI SPO2 ADT RE SENSOR; OXIMETER

Model Number	4050
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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.D4.A full udi is not available as the lot number for this sensor is unavailable.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 that the masimo sensor and cable provided an spo2 of 100% while blood gas analysis showed 85% and a 3rd party monitor showed 87%.There was no patient impact or consequence reported.

• Brand Name: DCI SPO2 ADT RE 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: 24934247
• Report Number: 3019388613-2026-00168
• Device Sequence Number: 16134390
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN 4078 RD RNBW PAT CABLE
• Patient Sex: Unknown