MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-97; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9797
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device saturation is intermittent.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the device is received for evaluation or new information is obtained, a follow up report will be submitted.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.H3 other text: product not returned.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.During evaluation the device passed all visual and functional testing.No product performance issues were found relating to intermittent saturation measurements.The device was confirmed to be functioning as designed.E1.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported that the device saturation is intermittent.There was no patient impact or consequence reported.

• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22974301
• Report Number: 3019388613-2025-00096
• Device Sequence Number: 9256552
• Product Code: MWI
• UDI-Device Identifier: 00843997012775
• UDI-Public: (01)00843997012775(11)241227
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 9797
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• 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