MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy Rad-97; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Model Number	9738
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported: "intermittent readings".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.The device was found to have recessed pins within the patient monitoring cable-connector port.This causes the device to display a "replace sensor" error message when attempting to obtain measurements.The customer's complaint was replicated in testing.Health effect impact code: no adverse event; no patient impact.

• Brand Name: Rad-97
• Common Device Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
• 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: 50578538
• Report Number: 3019388613-2026-00594
• Device Sequence Number: 18614677
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: (01)00843997012317(11)181201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 9738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2018
• 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