MAUDE Adverse Event Report: MASIMO CORPORATION O3; OXIMETER

Model Number	4235
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A patient had placement of nirs (near-infrared spectroscopy) monitors on the lower left flank.The patient developed an unstageable pressure injury at the location of the probe.

• Brand Name: O3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 15216530
• Report Number: 15216530
• Device Sequence Number: 20415459
• Product Code: DQA
• UDI-Device Identifier: 00843997010801
• UDI-Public: 00843997010801
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2022
• Report Date (Section F): 08/08/2022

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: 4235
• Device Catalogue Number: 4235
• 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: 08/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2022
• 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: 15 KG
• Patient Race: White
• Date Report Sent to FDA: 08/08/2022