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

Model Number	9695
Medical Device Problem Codes	Defective Alarm (1014); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.The device powered on and off when connected to ac power.However, the battery led illuminated red, indicating a battery fault.The device would not power on using battery power.The defective battery could not hold a charge, causing the device to power off immediately when disconnected from ac power.The reported issue was confirmed.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that the device is turning on but shuts down after an hour when the ac is unplugged, with no message or alarm provided.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.\ \ health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that the device is turning on but shuts down after an hour when the ac is unplugged, with no message or alarm provided.There was no patient impact or consequence reported.

• Brand Name: Root with NIBP and Temp
• 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: 50877317
• Report Number: 3019388613-2026-00688
• Device Sequence Number: 13067288
• Product Code: MWI
• UDI-Device Identifier: 00843997011907
• UDI-Public: (01)00843997011907(11)191220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191882
• 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): 08/26/2026

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: 9695
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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