BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLINX NEURON 2

    MDR report key: 13978531 · Received April 1, 2022

    Report

    Report Number
    3003630387-2022-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    September 3, 2022
    Report Date
    April 1, 2022
    Manufacturer
    CAPSULE TECHNOLOGIE SAS
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTING A FIRE WITH A NEURON 2. DETAILS ARE PENDING FROM THE CUSTOMER. CUSTOMER ADMITTED USING INCORRECT POWER SUPPLY FROM NEURON 1 WHICH THE IFU WARNS NOT TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089031 SMARTLINX NEURON 2 MEDICAL DEVICE DATA SYSTEM - MDDS OUG CAPSULE TECHNOLOGIE SAS NEURON 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown