MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number	4003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pulse oximeter new from package, did not read.Troubleshooted monitor and cables, determined to be pulse ox as prior pulse ox was reading.Monitor read with new pulse ox.Manufacturer response for oximeter, rd set (per site reporter).

• Brand Name: RD SET
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 19537153
• Report Number: 19537153
• Device Sequence Number: 6171421
• Product Code: DQA
• UDI-Device Identifier: 00843997009591
• UDI-Public: (01)00843997009591
• 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): 05/30/2024
• Report Date (Section F): 05/30/2024

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: 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: 06/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• 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: 05/30/2024