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 Skin Inflammation/ Irritation (4545)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

A reddened area was discovered to a pre-mature infant's right foot plantar area.The area was left open to air for 45 minutes, but the redness did not lessen.As of 5 days later, the skin injury is still visible and continues to heal.Manufacturer response for oximeter, masimoset® lncs® neo neonatal/adult pulse oximeter adhesive sensor (per site reporter).Investigation continues with ongoing multiple skin issue concerns with masimo products.

• Brand Name: MASIMOSET® LNCS®
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16494836
• MDR Text Key: 310792253
• Report Number: 16494836
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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: 02/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• 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: 1 DA
• Patient Sex: Female
• Patient Weight: 1 KG