BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET EDX

    MDR report key: 8499958 · Received April 10, 2019

    Report

    Report Number
    3010611950-2019-00019
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 20, 2019
    Manufacturer
    NATUS NEURO INCORPORATED
    Product Code
    GWF
    UDI-DI
    00382830037433
    PMA / PMN Number
    K112052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE (B)(4). PRODUCT RETURNED TO NATUS, DETERMINED ROOT CAUSE TO BE FAILED DC TO DC ENDICOTT CONVERTER.

    Description of Event or Problem · 1

    EDX BASE STARTED TO SMOKE HEAVILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295463 NICOLET EDX EDX BASE UNIT GWF NATUS NEURO INCORPORATED 515-015300 N/A 00382830037433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other