MAUDE Adverse Event Report: MASIMO CORPORATION RD NEO CS-2 WITH 2 FOOT CABLE; OXIMETER

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nodule (4551)

Event Date 08/19/2022

Event Type  Injury  

Event Description

Pulse oximeter site assessment noted a small hard circular area on left foot underneath the pulse oximeter.Fda safety report id# (b)(4).

• Brand Name: RD NEO CS-2 WITH 2 FOOT CABLE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 15536965
• MDR Text Key: 301168534
• Report Number: MW5112389
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic