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

Model Number	9500
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, 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-7 "powers off by itself." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned radical-7 was evaluated.The device powered on via battery and ac power, however, after booting up, the device powered off by itself and a watchdog alarm was triggered.This was caused by a short in two pins of the u21 component on the instrument board.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-7 "powers off by itself." there was no patient impact or consequence reported.

• 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: 24338027
• Report Number: 3019388613-2026-00042
• Device Sequence Number: 9754475
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)141113
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 9500
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2014
• 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