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

Model Number	9500
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the radical-7 and radius vsm were "reading higher than secondary pulse oximeter used and seems to be over reading.Patients who have known desaturations (due to pulmonary fibrosis), remain within normal limits on masimo, however desaturation noted on other devices." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
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.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; 9492977167
• MDR Report Key: 25482092
• Report Number: 3019388613-2026-00311
• Device Sequence Number: 13342883
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 05/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: RADIUS BATTERY MODULE AB0043863; RADIUS-7
• Patient Sex: Unknown