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 Blister (4537)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Intact blister found on foot while moving the pulse oximeter probe to the opposite foot during initial assessment.The pulse oximeter probe was over the site where the blister was found.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16245839
• MDR Text Key: 308158076
• Report Number: 16245839
• 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: 28 DA
• Patient Sex: Male
• Patient Weight: 4 KG