MAUDE Adverse Event Report: MASIMO CORPORATION RD SET NEO SPO2, PR, PI, PVI NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR

Model Number	4003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Pulse oximeter (pulse ox) probe stopped reading twice within 30 minutes.Monitor appeared with question mark.Patient was still and sleeping at the time.Pulse ox was verified in correct placement.Unplugged and replugged in - did not read.

• Brand Name: RD SET NEO SPO2, PR, PI, PVI NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 17649719
• Report Number: 17649719
• Device Sequence Number: 20695483
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: (01)10843997009598
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2023