BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROCOM EQUITEST

    MDR report key: 9293608 · Received November 7, 2019

    Report

    Report Number
    3018859-2019-00009
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    KHX
    PMA / PMN Number
    K946229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS TECHNICAL SERVICE PROVIDED THE CUSTOMER WITH TROUBLESHOOTING INSTRUCTIONS TO DETERMINE THE ROOT CAUSE FOR THE FAILURE. THE CUSTOMER WAS ABLE TO REPAIR THE DEVICE ON-SITE AND THE ISSUE WAS RESOLVED. THE UNINTENDED MOVEMENT OF THE SYSTEM MOTORS IS A MALFUNCTION IDENTIFIED IN THE RISK FILE AND THE SEVERITY OF POTENTIAL HARM IS RATED AS MODERATE AND THEREFORE DETERMINED REPORTABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, NATUS MEDICAL WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE CUSTOMER CONTACTED NATUS MEDICAL TO REPORT UNINTENDED MOTION ON THEIR SMART EQUITEST INVOLVING NATUS PN# A102884-00 (EQUITEST DYN BASE ASSY) SN# (B)(4) FOR A DEVICE REGISTERED TO CUSTOMER SITE ON (B)(6) 2017. THE BIO-MED TECHNICIAN NOTIFIED NATUS MEDICAL THAT A SYSTEM USER REPORTED THEY WERE IN THE PROCESS OF DISCONNECTING A PATIENT FROM THE SAFETY HARNESS AFTER COMPLETING A SENSORY ORGANIZATION TEST (SOT) WHEN THE VISUAL SURROUND FELL BACKWARD, AND THE DYNAMIC FORCE PLATE MOVED TOES DOWN. A FEW MINUTES LATER WHEN NOBODY WAS ON THE SYSTEM THE MOTORS RETURNED TO THE LEVEL POSITION WITHOUT ANY USER INTERACTION. THE SYSTEM USER CONFIRMED THAT THERE WERE NO INJURIES AS A RESULT OF THE EVENT. THE SYSTEM USER VERIFIED THAT THE SYSTEM CHECKS PASSED AND NO PROBLEMS WERE FOUND. NATUS TECHNICAL SUPPORT REPRESENTATIVE (TSR) RECOMMENDED THAT THE CUSTOMER BIOMEDICAL EQUIPMENT TECHNICIAN RUN THE MOTOR VELOCITY TESTS AND CYCLE THE SYSTEM MOTORS TO TRY AND DETERMINE THE ROOT CAUSE OF THE PROBLEM. THE TSR ALSO RECOMMENDED THAT THE CUSTOMER SHOULD REMOVE THE SYSTEM FROM SERVICE UNTIL THE PROBLEM IS FOUND AND REPAIRED. ON (B)(6) 2019, NATUS TSR MADE FOLLOW UP TO CHECK THE STATUS OF THE SYSTEM, THE CUSTOMER REPORTED FINDING A BAD CONNECTION ON 1 OF THE 7.5 AMP POLY SWITCHES ON THE MAIN POWER SUPPLY TRANSFORMER ASSEMBLY. THE CUSTOMER ALSO FOUND A LEAD WIRE ON THE POLY SWITCH WAS BENT OVER AND NOT MAKING A GOOD CONNECTION IN THE SPRING TERMINAL. THE CUSTOMER REMOVED THE POLY SWITCH, STRAIGHTENED THE BENT LEAD WIRE AND REINSTALLED THE POLY SWITCH CORRECTLY AND CONFIRMED THAT THE ISSUE DID NOT RECUR AND THEY CONSIDERED THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088318 NEUROCOM EQUITEST SMART EQUITEST KHX NATUS MEDICAL INCORPORATED NCM-SMEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other