MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number 4003

Device Problem Use of Device Problem (1670)

Patient Problem Erythema (1840)

Event Date 01/21/2023

Event Type  malfunction  

Event Description

Skin redness top of right foot after using sensor a few hours.Neonatal nurse practitioner reports that it was healed in less than 24 hours, so was not a burn or pressure injury.Manufacturer response for oximeter, rd set¿ neo spo2, pr, pi, pvi® neonatal/adult pulse oximeter adhesive sensor (per site reporter).In person root cause analysis.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 16466644
• MDR Text Key: 310525656
• Report Number: 16466644
• 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: 4003
• Device Catalogue Number: 4003
• 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: 1 DA
• Patient Weight: 3 KG