MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RADICAL-7; OXIMETER

Model Number	9500
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: device evaluation is anticipated.When the device is evaluated or new information is obtained, a follow-up report will be submitted.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).
Event or Problem Description
The customer reported the radical-7s' "mode changed unintentionally." per additional information from the customer, "the mode automatically switches from pediatric mode to neonatal mode." there was no patient impact or consequence reported.
Event or Problem Description
The customer reported the radical-7s' "mode changed unintentionally." per additional information from the customer, "the mode automatically switches from pediatric mode to neonatal mode." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned device was evaluated.During evaluation the device passed all visual and functional testing.Throughout testing and after each power cycle, the device remained in pediatric mode.The device was confirmed to be functioning as designed.Health effect impact code: no adverse event; no patient impact.(b)(6).

• Brand Name: RADICAL-7
• 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: 24254905
• Report Number: 3019388613-2026-00033
• Device Sequence Number: 8327357
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)221029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2022
• 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
• Patient Sex: Unknown