MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number	4478
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Model 4478- while on transport and while getting ready to intubate patient, oxygen saturation probe went flatline and stopped reading.After intubating patient and getting settled, replaced oxygen saturation probe with a new one and started working again.Model 2320- pulse oximeter low noise cabled sensor (lncs) found to have exposed wires.Model 2320- bedside registered nurse (rn) discovered oxygen saturation probe was frayed with exposed wires on infant¿s skin.No harm to patient.Model 4013- pulse oximeter flatlined on monitor.Noticed on central monitor but did not alarm.Went into room and baby was resting comfortably.Saturation monitor was still on foot and properly positioned.

• Brand Name: RD SET
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 19070607
• Report Number: 19070607
• Device Sequence Number: 4732580
• Product Code: DQA
• UDI-Device Identifier: 10843997013267
• UDI-Public: (01)10843997013267
• 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): 12/04/2023
• Report Date (Section F): 12/04/2023

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: 4478
• Device Catalogue Number: 4478
• 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: 12/04/2023