BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-97

    MDR report key: 24031600 · Received January 12, 2026

    Report

    Report Number
    3019388613-2026-00002
    Event Type
    Death
    Date Received
    January 12, 2026
    Date of Event
    January 1, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997012317
    PMA / PMN Number
    K212161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.).

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96158 RAD-97 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 9738 00843997012317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SUNSET NEO-M-1.5 DISPOSABLE SPO2 SENSOR, RES7200.