MAUDE Adverse Event Report: MASIMO CORPORATION MASIMOSET® LNCS® NEO NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR

Model Number	2329
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Connected to the monitor and would not read.Biomed had checked monitor and was functioning as expected.

• Brand Name: MASIMOSET® LNCS® NEO NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 21025839
• Report Number: 21025839
• Device Sequence Number: 8995059
• Product Code: DQA
• UDI-Device Identifier: 00843997000925
• UDI-Public: (01)00843997000925
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2024
• Report Date (Section F): 11/27/2024

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
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Device Lot Number: 24HN8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• 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: Male
• Date Report Sent to FDA: 11/27/2024