MAUDE Adverse Event Report: MASIMO CORPORATION RD SET NEO; OXIMETER

Lot Number 21NPR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Erythema (1840)

Event Date 01/23/2022

Event Type  Injury  

Event Description

Neonate with reddened skin in area where skin probe was applied on right wrist.Fda safety report id# (b)(4).

• Brand Name: RD SET NEO
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; irvine CA 92618
• MDR Report Key: 13416843
• MDR Text Key: 284870175
• Report Number: MW5107092
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 21NPR
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White