MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number 4003

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

Parents pointed out to this rn that infant had received a wound on a previous shift from the pulse ox probe.This rn noted there was a red mark on the top of the infant's foot that was in the same location the pulse ox probe would lie.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16245786
• MDR Text Key: 308159594
• Report Number: 16245786
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4003
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2023
• 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: 12 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic