BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROCOM EQUITEST

    MDR report key: 7737403 · Received July 31, 2018

    Report

    Report Number
    3018859-2018-00135
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 29, 2018
    Report Date
    July 2, 2018
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    KHX
    PMA / PMN Number
    K946229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS TECHNICAL SERVICE CONFIRMED THAT THE SYSTEM WAS FROZEN WHILE TROUBLESHOOTING THE ISSUE REMOTELY WITH THE COMPLAINANT. NATUS TECHNICAL SERVICE WALKED THE COMPLAINANT THROUGH TURNING OFF THE DYNAMIC PLATFORM AND DISCONNECTING POWER TO THE COMPUTER. AFTER LETTING THE SYSTEM REST FOR AT LEAST A MINUTE, POWER WAS RECONNECTED. THE SYSTEM THEN OPERATED CORRECTLY AND THE FAILURE COULD NO LONGER BE DUPLICATED. NATUS TECHNICAL SERVICE ADVISED THE COMPLAINANT TO CONTINUE MONITORING THE SYSTEM AND CONTACT NATUS SHOULD THE ISSUE REOCCUR. BECAUSE THE ISSUE RESOLVED ITSELF AFTER CYCLING POWER TO THE SYSTEM, THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NATUS THAT DURING A GAZE STABILIZATION TEST (GST), THE SMART EQUITEST SYSTEM FROZE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575837 NEUROCOM EQUITEST SMART EQUITEST KHX NATUS MEDICAL INCORPORATED NCM-SMEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other