MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G YI MULTISITE REUSABLE SENSOR; OXIMETER

Model Number	4653
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that "it took several minutes for the machine to try to read after attaching the sensor to the patient, and once it did, it began reading on and off for several minutes.This last occurrence, it took me 10 minutes to get a read, with multiple times rebooting the device.Sensor is reading 60% spo2 and 60 pr".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the sensor has not been returned to the investigation facility to allow for an analysis to be performed.If the sensor 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 "it took several minutes for the machine to try to read after attaching the sensor to the patient, and once it did, it began reading on and off for several minutes.This last occurrence, it took me 10 minutes to get a read, with multiple times rebooting the device.Sensor is reading 60% spo2 and 60 pr".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 have a stable signal with no dropouts throughout the duration of testing.The sensor was confirmed to be functioning as designed.Health effect impact code: no adverse event; no patient impact.

• Brand Name: RAD-G YI MULTISITE REUSABLE SENSOR
• 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24338637
• Report Number: 3019388613-2026-00044
• Device Sequence Number: 15895933
• Product Code: DQA
• UDI-Device Identifier: 00843997015530
• UDI-Public: (01)00843997015530(11)231201(10)23MDM
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 4653
• Device Lot Number: 23MDM
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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