MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY NEO/ADULT PULSE OX ADH SENSOR; OXIMETER

Model Number	4473
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: the masimo representative has confirmed the sensor will not return to allow an analysis to be performed.If the sensor 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.
Event or Problem Description
The customer reported that "the spo2 value measured by mindray/masimo was "falsely" low compared with former philips/fast monitor with nellcor sensor and abg sao2: mindray/masimo - left hand: spo2 = 86; philips mp2/fast - foot: spo2 = 94; abg: sao2 = 92.4; 4 - 6 pts difference".There was no patient impact or consequence reported.

• Brand Name: NEO/ADULT PULSE OX ADH 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: 24506685
• Report Number: 3019388613-2026-00070
• Device Sequence Number: 13251796
• Product Code: DQA
• UDI-Device Identifier: 10843997013229
• UDI-Public: (01)10843997013229
• 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
• Report Date (Section B): 02/04/2026

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
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• 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 100293; PN 4474
• Patient Age: 4 MO
• Patient Sex: Unknown