MAUDE Adverse Event Report: MASIMO CORPORATION O3; OXIMETER

Model Number 4235

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

Patient Problem Pressure Sores (2326)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Patient had placement of nirs (near-infrared spectroscopy) monitors on right and left flanks and developed pressure injuries at both sites.

• Brand Name: O3
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 15216491
• MDR Text Key: 297776229
• Report Number: 15216491
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997010801
• UDI-Public: 00843997010801
• 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: 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
• Date Report Sent to FDA: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2022
• 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: 1095 DA
• Patient Sex: Female
• Patient Weight: 12 KG