MAUDE Adverse Event Report: MASIMO CORPORATION MASIMOSET LNCS; OXIMETER

Model Number 2329

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

Patient Problem Ulcer (2274)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Stage 1 pressure injury; pulse ox probe was removed from injured site and placed on right foot with some mepitil lite foam to inside of pulse ox at transmitter light.

• Brand Name: MASIMOSET LNCS
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 16470715
• MDR Text Key: 310542908
• Report Number: 16470715
• Device Sequence Number: 1
• Product Code: DQA
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 DA
• Patient Weight: 2 KG