MAUDE Adverse Event Report: MASIMO CORPORATION O3 SENSOR RSO2 INFANT/NEONATAL ADHESIVE SENSOR; OXIMETER, TISSUE SATURATION

Model Number	4384
Health Effect - Clinical Codes	Skin Tears (2516); Superficial (First Degree) Burn (2685)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Nirs probes placed on patients have resulted in different injuries, including skin tears, burns, and pressure injuries.
Event or Problem Description
Near-infrared spectroscopy (nirs) probe placed on right flank resulted in stage 2 pressure injury.

• Brand Name: O3 SENSOR RSO2 INFANT/NEONATAL ADHESIVE SENSOR
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16311002
• Report Number: 16311002
• Device Sequence Number: 15145509
• Product Code: MUD
• UDI-Device Identifier: 10843997013496
• UDI-Public: (01)10843997013496(17)250401(10)22DNY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022
• Report Date (Section F): 12/02/2022

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: 4384
• Device Lot Number: 22DNY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 12/02/2022