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

Model Number	9797
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device will not power on most of the time.If it does turn on, it shuts off by itself.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned product was evaluated.The device powered on using both battery and ac power.However, the display became inactive, followed by an alarm condition consisting of one long beep and two short beeps, while the home button flashed red continuously.An internal inspection identified a defective solder joint at the u15 chip on the mx-7 tech board, which prevented completion of the power-on sequence.Additionally, the device log files also recorded an ¿mmxbi board failure" error message.The reported issue was confirmed.Health effect impact code: no adverse event; no patient impact.

• Brand Name: Rad-97 with NIBP
• 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: 50910730
• Report Number: 3019388613-2026-00700
• Device Sequence Number: 5330780
• Product Code: MWI
• UDI-Device Identifier: 00843997012775
• UDI-Public: (01)00843997012775(11)250711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 9797
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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