MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY LNCS TC-I REUSABLE EAR SENSOR; OXIMETER

Model Number	1895
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported "a patient hospitalized for type 2 respiratory failure and ventilated with niv presented a marked discrepancy between the measured saturation values (spo2 89¿91%) and the results of several successive blood gas analyses, indicating severe hypoxemia.Clinical checks showed no deterioration, and the spo2 signal appeared to be of adequate quality (perfusion index 1.25).Per the reported information, the patient did not experience any complications nor serious consequences.
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.4581: hypoxemia, h3 other text: sensor not received.
Additional Manufacturer Narrative
Other, other text: the returned sensors and concomitant cable were evaluated.A missing hinge pin was found during visual inspection of the lncs tc-i sensor.In this condition, the sensor was unable to engage in monitoring, and therefore, the accuracy issue could not be duplicated.The db-i sensor and cable were able to obtain spo2 and pulse rate readings during functional testing.The db-i sensor and cable were determined to be functioning as designed.Health effect clinical code: hypoxemia.D1.Concomitant medical products exceeded allowable field length, concomitant medical products are as follows: lncs db-i sensor (lot 23kbd) and lnc-10 patient cable (lot 23ceg).
Event or Problem Description
The customer reported "a patient hospitalized for type 2 respiratory failure and ventilated with niv presented a marked discrepancy between the measured saturation values(spo2 89¿91%) and the results of several successive blood gas analyses, indicating severe hypoxemia.Clinical checks showed no deterioration, and the spo2 signal appeared to be of adequate quality (perfusion index 1.25).Per the reported information, the patient did not experience any complications nor serious consequences.

• Brand Name: LNCS TC-I REUSABLE EAR 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 ; 9492977862
• MDR Report Key: 23550494
• Report Number: 3019388613-2025-00155
• Device Sequence Number: 21194376
• Product Code: DPZ
• UDI-Device Identifier: 00843997000048
• UDI-Public: (01)00843997000048(11)230704(10)23F8K
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1895
• Device Catalogue Number: 1895
• Device Lot Number: 23F8K
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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: NIV VENTILATION MACHINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male