MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RADIUS VSM; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9037
Medical Device Problem Codes	No Display/Image (1183); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the disappearance "of temperature and nibp measurement" on the radius vsms.Measurements from the vsm showed up blank on the psn and there was no error nor alarm triggered.There was no patient impact or consequence reported.
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.D11.Concomitant medical products: the customer reported electrode leads and a blood pressure module were used in conjunction with the suspect medical device.However, the specific lot number of the electrode leads used could not be determined.Therefore, both electrode lead lot numbers were included in as concomitant products in this mdr.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the disappearance "of temperature and nibp measurement" on the radius vsms.Measurements from the vsm showed up blank on the psn and there was no error nor alarm triggered.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned radius vsm was evaluated.The device was able to obtain measurements for all enabled parameters.The radius vsm was able to connect to the safetynet system and both the vsm and the safetynet system would audible and visually alarm when the alarm limits were breached.No product performance issues related to temperature or blood pressure readings were identified during testing.The device was determined to be functioning as designed.Health effect impact code: no adverse event, no patient impact.

• Brand Name: RADIUS VSM
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITH 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 ; 9492977167
• MDR Report Key: 24601451
• Report Number: 3019388613-2026-00088
• Device Sequence Number: 18234230
• Product Code: MHX
• UDI-Device Identifier: 00843997019163
• UDI-Public: (01)00843997019163(11)250327
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K223498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 9037
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 05/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECG ELECTRODES, (25D10, 25FBR), TWO NIBP MODULES,PSN.
• Patient Sex: Unknown