BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIKING EDX

    MDR report key: 3216955 · Received July 8, 2013

    Report

    Report Number
    3008289288-2013-00012
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    GWF
    PMA / PMN Number
    K112052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPAIRED AND IS STILL USING THE DEVICE AND WILL NOT BE RETURNING THE DEVICE TO US FOR EVAL.

    Description of Event or Problem · 1

    BOLT BROKE OFF OF AMPLIFIER ARM CAUSING THE AMPLIFIER TO DROP. THE AMPLIFIER COULD HAVE DROPPED ONTO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311584 VIKING EDX VIKING EDX GWF NATUS NEUROLOGY INCORPORATED 982A0589 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other