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

Model Number	9738
Medical Device Problem Codes	Accessory Incompatible (1004); Failure to Sense (1559)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	01/01/2025
Type of Reportable Event	Death
Event or Problem Description
The customer reported "on (b)(6) 2025, prompt care was notified that a patient using a sunset healthcare solutions spo2 sensor with the rad 97 masimo died after going brain dead because the system did not alarm." based on the medical device problem codes, it was reported the accessory was incompatible and a failure to sense.
Additional Manufacturer Narrative
Other text: masimo has reached out to the manufacture identified on the report in the maude database to request the return of the device and additional information surrounding the event.The device has not been returned to masimo to allow for an analysis to be performed, as of the date of this report no further information was obtained.Masimo is unable to confirm if there was a problem with the device.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.The directions for use (dfu) provided a warning: "only use masimo authorized devices with rad-97.Using unauthorized devices with rad-97 may result in damage to the device and/or patient injury." "all sensors and cables are designed for use with specific devices.Verify the compatibility of the device, cable, and sensor before use; otherwise, degraded performance and/or patient injury can result." the initial reporter's information is unknown (e.1.).

• 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: 24031600
• Report Number: 3019388613-2026-00002
• Device Sequence Number: 9058050
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: (01)00843997012317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9738
• Was Device Available for Evaluation?: No
• 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: 12/15/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SUNSET NEO-M-1.5 DISPOSABLE SPO2 SENSOR, RES7200.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown