MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET; OXIMETER

Model Number	4478
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch report (b)(4), the customer reported that the sensor "was reading sensor malfunction off and on throughout the day with large variations in oxygen saturation at times that would quickly resolve".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was found to provide spo2 and pulse rate values throughout the entire duration of testing.The sensor was confirmed to be functioning as designed.

• Brand Name: RD SET
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEDICAL TECHNOLOGIES (MALAYSIA) SDN BHD; lot 198512, (plo 547-b) jalan keluli 11, zon 12a; kawasan perindustrian pasir gudang 81700 ; MY 81700
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 21699128
• Report Number: 3019388613-2025-00019
• Device Sequence Number: 21140838
• Product Code: DQA
• UDI-Device Identifier: 10843997013267
• UDI-Public: (01)10843997013267(17)270701(10)24GZ2
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4478
• Device Lot Number: 24GZ2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CABLE LOT E24FEC AND RD SET SENSOR LOT 23NQR
• Patient Sex: Unknown