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

Model Number	4478
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was able to obtain spo2 and pulse rate values.The unit was determined to be functioning as designed.
Event or Problem Description
Per medwatch (b)(4) the customer reported that the "patient's monitor said that the pulse oximeter was off patient.The sensor was still on the patient and everything was connected." there was no patient impact or consequence reported.

• 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 - 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: 20363886
• Report Number: 3019388613-2024-00120
• Device Sequence Number: 12482241
• Product Code: DQA
• UDI-Device Identifier: 10843997013267
• UDI-Public: (01)10843997013267(17)261201(10)23NFP
• Combination Product (Y/N): N
• 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): 09/11/2024

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 Model Number: 4478
• Device Lot Number: 23NFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2023
• 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
• Patient Sex: Unknown