MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number 4003

Patient Problem Insufficient Information (4580)

Event Date 07/27/2023

Event Type  malfunction  

Event Description

As per nursing leadership, the sensors were tested and shown to have difficulty sensing o2 saturation and pulse.Two sets of lot numbers pulled from use.Masimo reps were notified at that time.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 17806810
• MDR Text Key: 324133330
• Report Number: 17806810
• 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: 08/23/2023

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
• Device Catalogue Number: 4003
• Device Lot Number: 23ZBC, 23FMZ
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2023
• Date Report to Manufacturer: 09/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1