MAUDE Adverse Event Report: MASIMO CORPORATION O3; OXIMETER, TISSUE SATURATION

Model Number	4384
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Near-infrared spectroscopy (nirs) probe on the right flank resulted in a stage 1 pressure ulcer/injury.

• Brand Name: O3
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 16459141
• Report Number: 16459141
• Device Sequence Number: 11366548
• 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
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/21/2023

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: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• 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: 5 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 02/21/2023