BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO LNS >40KG

    MDR report key: 24519392 · Received March 5, 2026

    Report

    Report Number
    24519392
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 16, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW PULSE OX SENSOR NOTED TO HAVE EXPOSED WIRES WHEN REMOVING FROM PACKAGE. SENSOR REPLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576883 MASIMO LNS >40KG OXIMETER DQA MASIMO CORPORATION 25HZ4 (ON BACK OF SENSOR)

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other