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

Model Number	9500
Medical Device Problem Codes	Device Alarm System (1012); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: masimo received this device at the regional facility in japan; however, the device was requested to be returned with no investigation by the customer.If new information is obtained, or the device is received for analysis a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact e1.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported that the device indicates a full charge when used on its own, but when it is connected to the docking station and the power cord is unplugged, the unit shuts down with no message or alarm.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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; 9492977167
• MDR Report Key: 25437666
• Report Number: 3019388613-2026-00300
• Device Sequence Number: 10321920
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)140819
• 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
• Report Date (Section B): 05/17/2026

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?: No
• 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: 05/17/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN 1310 RDS-1 SN. (B)(6).
• Patient Sex: Unknown