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

Model Number	3924
Medical Device Problem Codes	Device Alarm System (1012); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the device is received for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that the device provides intermittent readings with no alarm or error messages displayed on the host monitor.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned module was evaluated.During evaluation the module passed all visual and functional testing.The device was able to get measurements without interruption during testing.The module was found to visually and audibly alarm during alarm conditions.The module was confirmed to be functioning as designed.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that the device provides intermittent readings with no alarm or error messages displayed on the host monitor.There was no patient impact or consequence reported.

• Brand Name: INTELLIVUE
• 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: 22775347
• Report Number: 3019388613-2025-00081
• Device Sequence Number: 9621547
• Product Code: DQA
• UDI-Device Identifier: 00843997011495
• UDI-Public: (01)00843997011495(11)200128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2025

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: 3924
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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
• Patient Sex: Unknown