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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported "returned from a patient because the connection between the rad and the sensor is faulty.The device regularly loses data.Test performed with the m20 tester; same problem - the rad has great difficulty receiving data." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the device was evaluated.It powered on using both battery and ac power.However, a replace sensor error message appeared when a known-good sensor was connected, and measurements could not be obtained.The issue was determined to be caused by a bent pin in the tb20 connector.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).

• 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: 50170081
• Report Number: 3019388613-2026-00495
• Device Sequence Number: 9880484
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: (01)00843997012317(11)250212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 08/06/2026
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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