MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY ROOT WITH BLOOD PRESSURE AND TEMPERATURE; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9695
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 h3 other text: device not returned.
Event or Problem Description
The customer reported a root "temperature issue" as the device was "reading [the] wrong temp." per additional information from the customer, "the readings were inconsistent and fluctuated unexpectedly." the following sequence of readings were observed: 98.2, 99.1, 99.4, and 98.4.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned root was evaluated; however, the customer temperature probe was not returned for analysis.The device was able to obtain measurements for all enabled parameters.No product performance issues related to temperature measurements were identified when the root was tested with a lab temperature probe.The device was determined to be functioning as designed.
Event or Problem Description
The customer reported a root "temperature issue" as the device was "reading [the] wrong temp." per additional information from the customer, "the readings were inconsistent and fluctuated unexpectedly." the following sequence of readings were observed: 98.2, 99.1, 99.4, and 98.4.There was no patient impact or consequence reported.

• Brand Name: ROOT WITH BLOOD PRESSURE AND TEMPERATURE
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 23519167
• Report Number: 3019388613-2025-00150
• Device Sequence Number: 9769988
• Product Code: MWI
• UDI-Device Identifier: 00843997011907
• UDI-Public: (01)00843997011907(11)231207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153225
• 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,Followup
• Report Date (Section B): 10/13/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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