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	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.H3 other text: product not returned.
Event or Problem Description
The customer reported that the device has a charging problem.When leaving the unit running on battery, once the charge gets to 75%, the unit shuts off.There was no alarm or error notification.
Additional Manufacturer Narrative
Other text: this supplemental mdr corrects the year masimo was made aware of this complaint.G4.Date received by manufacturer updated from 06-feb-2025 to 06-feb-2026.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact h3 other text : product not returned.
Event or Problem Description
The customer reported that the device has a charging problem.When leaving the unit running on battery once the charge gets to 75% the unit shuts off.There was no alarm or error notification.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: 24504454
• Report Number: 3019388613-2026-00067
• Device Sequence Number: 10509889
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)250814
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 02/06/2026

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: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 04/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/06/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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