BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-LOGIC NAVIGATOR PRO

    MDR report key: 7111418 · Received December 12, 2017

    Report

    Report Number
    3018859-2017-01021
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    November 9, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWJ
    PMA / PMN Number
    K083371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL TECH SUPPORT GAVE INSTRUCTION TO CUSTOMER TO TROUBLESHOOT DEVICE VIA EMAIL. THE CUSTOMER WAS CONTACTED SEVERAL TIMES ON UPDATES OF DEVICE WITHOUT ANY RESPONSE FROM THE CUSTOMER. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    NATUS TECHNICAL SERVICE REQUESTED THAT THE COMPLAINANT PERFORM A SELF-DIAGNOSTIC TEST USING THE LOOP TEST CABLE AND PROVIDED REFERENCE MATERIAL ON HOW TO PERFORM THE TEST. NO RESPONSE WAS RECEIVED TO THIS REQUEST. NO RESPONSE WAS RECEIVED TO TWO SUBSEQUENT FOLLOW-UP ATTEMPTS BY NATUS TECHNICAL SERVICE. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON (B)(6) 2017 THAT THEY WERE OBSERVING HIGH LEVELS OF ARTIFACT IN THEIR EEG READINGS OF THE LEFT EAR USING A NAVIGATOR PRO. THE CUSTOMER ALSO REPORTED THAT THE INSERT EARPHONE WAS CONTINUOUSLY CLICKING. THE CUSTOMER CHECKED THE NAVIGATOR PRO UNIT AND INSERT EARPHONE FOR DAMAGE BUT FOUND NONE. SERIAL #: (B)(4), PART #: 580-NAVPR2 (NAVIGATOR PRO), INSTALLED: (B)(6) 2016. THE CUSTOMER CONFIRMED THERE WAS NO DEATH/ SERIOUS INJURY, DELAY IN TREATMENT. CUSTOMER HAD CONCERNS WITH ENVIRONMENTAL OR SAFETY DUE TO A BURN SMELL.

    Description of Event or Problem · 1

    THE COMPLAINANT DID NOT REPORT THAT THERE WAS A BURNING SMELL, NOR WERE THERE ANY REPORTED ENVIRONMENTAL OR SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886742 BIO-LOGIC NAVIGATOR PRO NAVIGATOR PRO GWJ NATUS MEDICAL INCORPORATED 580-NAVPR2

    Patients

    Seq Age Sex Outcome Treatment
    1