BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ CYCLOPS CART

    MDR report key: 9370907 · Received November 25, 2019

    Report

    Report Number
    9612330-2019-00009
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 1, 2019
    Manufacturer
    NATUS MEDICAL INC. DBA EXCEL-TECH LTD (XLTEK)
    Product Code
    GWQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CART WAS MANUFACTURED IN 2011. THIS DEVICE WAS BEYOND ITS EXPECTED USEABLE LIFE. FIELD SERVICE WAS DISPATCHED TO REPLACE THE BASE OF THE CART.

    Description of Event or Problem · 1

    WHEEL FELL OFF OF CART BASE AND CART FELL ON TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164891 IP PTZ CYCLOPS CART ELECTROENCEPHALGRAPH GWQ NATUS MEDICAL INC. DBA EXCEL-TECH LTD (XLTEK) 015045

    Patients

    Seq Age Sex Outcome Treatment
    1