BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS

    MDR report key: 2223419 · Received August 18, 2011

    Report

    Report Number
    2223419
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADHESIVE SENSOR IS BECOMING DETACHED FROM THE CABLE AND EXPOSING WIRES AND THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LNCS OXIMETER, PROBE DQA MASIMO CORPORATION 1F553 00843997000925

    Patients

    Seq Age Sex Outcome Treatment
    1 *