BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET ONE MONITOR ON ERGO CART

    MDR report key: 3060308 · Received April 11, 2013

    Report

    Report Number
    3008289288-2013-00003
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 9, 2013
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    OLV
    PMA / PMN Number
    K021185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN PRODUCT IS SHIPPED TO THE CUSTOMER, THERE ARE SEVERAL SETS OF SCREWS AND INSTRUCTIONS EXPLAINING WHICH SCREWS TO USE WHERE. THE CUSTOMER INSERTED INCORRECT SHORTER SCREWS WHICH CAUSED THE PC TO FALL. WE HAVE ADDED CLEARER INSTALLATION INSTRUCTIONS STARTING IN (B)(6) 2013 TO SYSTEMS SHIPPED.

    Description of Event or Problem · 1

    PANEL PERSONAL COMPUTER FELL OFF MOUNT, HANGING FROM CABLES. THERE WAS NO PATIENT OR USER INJURY, BUT IF THEY WERE BELOW THE COMPUTER WHEN IT FELL, THEY COULD HAVE BEEN HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154304 NICOLET ONE MONITOR ON ERGO CART NICOLET ONE MONITOR ON ERGO CART OLV NATUS NEUROLOGY INCORPORATED 982A0500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other