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

Model Number	9799
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the returned rad-97 was evaluated.Heat damage was observed around the nurse call port with the most significant heat damage at the connection point for the external call cable that connects the rad-97 to 3rd party equipment.The exact cause of the heat damage could not be determined.The customer noted "sometimes nurses will use a stereo plug into the nurse call connector rather than mono." health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the rad-97 "caught on fire" and "burn a hole through the plastic." per additional information of the reported issue, the device "was being used on a patient at the time" and "there was smoke from the device and an electrical smell." no patient impact or consequences were 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24079279
• Report Number: 3019388613-2026-00009
• Device Sequence Number: 5878960
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: (01)00843997012782(11)190306
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 9799
• Device Catalogue Number: 9799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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