MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY MASIMOSET LNCS DCI SPO2 ADULT REUSABLE FINGER CLIP; OXIMETER

Model Number	1863
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the sensor "seems to be malfunctioning now as the light is intermittent and we keep losing trace of patients' oxygen levels during surgery." no patient impact or consequences were reported.
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the sensor.The sensor has not been returned to masimo 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.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: bt36 4aa.Health effect impact code: no adverse event, no patient impact.

• Brand Name: MASIMOSET LNCS DCI SPO2 ADULT REUSABLE FINGER CLIP
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22527558
• Report Number: 3019388613-2025-00068
• Device Sequence Number: 9265184
• Product Code: DQA
• UDI-Device Identifier: 00843997000406
• UDI-Public: (01)00843997000406(11)240903(10)24JFQ
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 1863
• Device Catalogue Number: 1863
• Device Lot Number: 24JFQ
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2024
• 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