BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUNSET NEO-M-1.5 DISPOSABLE SPO2 SENSOR

    MDR report key: 23203231 · Received October 2, 2025

    Report

    Report Number
    3006446479-2025-00002
    Event Type
    Death
    Date Received
    October 2, 2025
    Report Date
    October 2, 2025
    Manufacturer
    SHENZHEN MEDKE TECHNOLOGY CO., LTD
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 09/04/2025, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457350 SUNSET NEO-M-1.5 DISPOSABLE SPO2 SENSOR DISPOSABLE SPO2 SENSOR DQA SHENZHEN MEDKE TECHNOLOGY CO., LTD RES7200 GD202503050028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death