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

Model Number	4050
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported a measured spo2 value of 98% compared to 82.5% with the blood gas analyzer.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor and concomitant cable were evaluated.During evaluation the sensor and cable passed all visual and functional testing.During simulation testing, the sensor and cable passed manual and preset conditions and provided accurate measurements.The sensor and cable were determined to be functioning as designed.
Event or Problem Description
The customer reported a measured spo2 value of 98% compared to 82.5% with the blood gas analyzer.No patient impact or consequences were reported.

• Brand Name: RD SET DCI
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17302920
• Report Number: 3019388613-2023-00176
• Device Sequence Number: 7213835
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: 00843997009843
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 4050
• Device Catalogue Number: 4050
• Device Lot Number: 22F71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: RD RAINBOW SET R25-12 CABLE (LOT 22AFP)
• Patient Sex: Unknown