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	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when powering on, turns off by itself, and only powers on with the power cord.Per customer, "no error messages are displayed." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.During the evaluation, the device powered on using both battery and ac power.However, after displaying the splash screen, the display went blank, followed by an alarm state consisting of seven beeps.During evaluation it was determined a defective speaker prevented the device from completing the power-on sequence and generating the alarm.Additionally, an ¿audio speaker fault" error message was identified in the device log files.The reported issue was confirmed during testing.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: 50684702
• Report Number: 3019388613-2026-00608
• Device Sequence Number: 20125431
• Product Code: MWI
• UDI-Device Identifier: 00843997012775
• UDI-Public: (01)00843997012775(11)250710
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/14/2026

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: 08/17/2026
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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