MAUDE Adverse Event Report: MASIMO CORPORATION RD SET NEOPT-500 SPO2, PR, PI, PVI NEONATAL PULSE OXIMETER NON-ADHESIVE SENSOR

Model Number	4005
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
4005- monitor read equipment malfunction and the patient's oxygen saturation stopped reading.Upon inspecting faulty pulse oximeter, registered nurse (rn) noticed the black and gold area, the end that connects into the monitor end, had peeled up and was bent.4478- exposed wires.4478- exposed wires.4478- pulse oximeter failure - was reading well prior to intubation, patient locked chest during intubation medication.Saturations began to drop, saw 60, 50s, and then was unreadable during intubation until it finally came back after patient was stabilized and saturations were 80s again.4478- o2 saturation probe stopped working.It was unplugged and plugged back in and tried another limb.The red light did not come on.

• Brand Name: RD SET NEOPT-500 SPO2, PR, PI, PVI NEONATAL PULSE OXIMETER NON-ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 19069791
• Report Number: 19069791
• Device Sequence Number: 4631409
• Product Code: DQA
• UDI-Device Identifier: 10843997009895
• UDI-Public: (01)10843997009895
• 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): 03/21/2024
• Report Date (Section F): 03/21/2024

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: 4005
• Device Catalogue Number: 4005
• Device Lot Number: 22JTU
• 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: 04/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• 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: 03/21/2024