MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO CS-3; OXIMETER

Model Number	4478
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing and provided accurate measurements when connected to a lab monitor.The sensor was determined to be functioning as designed.
Event or Problem Description
The customer reported "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." there was no patient impact or consequence reported.

• Brand Name: RD SET NEO CS-3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19226319
• Report Number: 3019388613-2024-00049
• Device Sequence Number: 7640135
• Product Code: DQA
• UDI-Device Identifier: 10843997013267
• UDI-Public: 10843997013267
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: 4478
• Device Catalogue Number: 4478
• Device Lot Number: 23CRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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: LNC MP10 CABLE; LOT 23KAM; LOT 23NCEPART NUMBER 2281; PART NUMBER 4105; RD TO LNC ADAPTER CABLE
• Patient Sex: Unknown