BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-LOGIC NAVIGATOR PRO

    MDR report key: 3653187 · Received November 12, 2013

    Report

    Report Number
    1419887-2013-00002
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    October 15, 2013
    Report Date
    November 11, 2013
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    GWF
    PMA / PMN Number
    K083371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POWER SUPPLY IS A MEDICAL GRADE POWER SUPPLY MANUFACTURED BY GLOBTEK, INC. POWER SUPPLY WAS RETURNED BY DISTRIBUTOR AND WAS SENT TO GLOBTEK FOR ROOT CAUSE INVESTIGATION 11/07/2013. A COMPLAINT REVIEW OF BIO-LOGIC DEVICES USING THE GLOBTEK POWER SUPPLY DOES NOT REVEAL ANY FAILURES TO THIS EXTENT. THIS IS AN INITIAL REPORT. DUE TO THE SEALED NATURE OF THE POWER SUPPLY HOUSING, A VISUAL INSPECTION CONFIRMED THE BURNED/MELTED EXTERIOR BUT GLOBTEK IS REQUIRED TO PROVIDE A DETAILED ANALYSIS OF FAILURE.

    Description of Event or Problem · 1

    POWER SUPPLY USED WITH NAVIGATOR PRO DEVICE OVERHEATED TO THE REPORTED POINT OF FLAME. NO INJURIES OR OTHER DAMAGE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584552 BIO-LOGIC NAVIGATOR PRO NAV PRO GWF NATUS MEDICAL INC. 580-NAVPR2

    Patients

    Seq Age Sex Outcome Treatment
    1