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

Model Number 4384

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Near-infrared spectroscopy (nirs) probe on mid back (spine) resulted in a medical adhesive related skin injury (marsi) with partial thickness.

• Brand Name: O3
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 16459202
• MDR Text Key: 310424807
• Report Number: 16459202
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 10843997013496
• UDI-Public: (01)10843997013496(17)250401(10)22DNY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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
• Date Report Sent to FDA: 02/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 330 DA
• Patient Sex: Female
• Patient Ethnicity: Hispanic