BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET VEEG SYSTEM

    MDR report key: 5068889 · Received September 10, 2015

    Report

    Report Number
    3010611950-2015-00018
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    NATUS NEUROLOGY, INCORPORATED
    Product Code
    GWQ
    PMA / PMN Number
    K964280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RE-FILING OF REPORT 3008289288-2014-00005 WITH A NEW REPORT NUMBER. THE REPORT WAS EDITED ON (B)(4) 2015 TO REVISE THE FACILITY REGISTRATION NUMBER FROM 3008289288 TO 3010611950. THE CURRENT FACILITY REGISTRATION NUMBER CHANGED IN MAY 2014 WHEN NATUS NEUROLOGY INC. MOVED TO ITS CURRENT LOCATION AT (B)(4). PATIENT INFORMATION: PATIENT INFORMATION WAS NOT PROVIDED, PATIENT AGE AND WEIGHT ARE THEREFORE DEFAULTED TO "0". DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. REGISTERED INTERNALLY AS A COMPLAINT (REFERENCE (B)(4)) FOR FURTHER INVESTIGATION BY MANUFACTURER. THE INTERNAL INVESTIGATION CONFIRMED THAT THE CART DESIGN HAD BEEN SUCCESSFULLY TIP TESTED BY THE MANUFACTURER AND THAT THE SYSTEM IN QUESTION MAY HAVE CAUGHT ON A THRESHOLD REQUIRING THAT AN UNUSUAL AMOUNT OF FORCE BE USED TO TRY AND MOVE IT WHICH INADVERTENTLY TIPPED THE CART.

    Description of Event or Problem · 1

    A HOSPITAL TECHNICIAN WAS MOVING A NATUS NEUROLOGY NICONE VEEG MONITORING SYSTEM ON A ROLL-ABLE ERGOTRON CART INTO/THROUGH AN ELEVATOR. THE CART TIPPED OVER INJURING THE TECHNICIAN. CART LABELING REQUIRES THAT THE SYSTEM MUST NOT EXTEND UP OR OUT AND THAT CARE MUST BE USED WHEN PUSHING OR PULLING CARTS OVER DEPRESSED SURFACES. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598490 NICOLET VEEG SYSTEM ELECTROCEPHLOGRAPH SYSTEM GWQ NATUS NEUROLOGY, INCORPORATED 982A0506

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other