MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy Radical-7; Oximeter

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported there was a sudden drop in spo2 readings.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the device is received 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 zip code exceeded allowable field length, initial reporter 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 ; +1(949)297-7167
• MDR Report Key: 50941805
• Report Number: 3019388613-2026-00709
• Device Sequence Number: 10735138
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)140331
• 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
• Report Date (Section B): 09/03/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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