BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CART (W/O UPS)

    MDR report key: 11280838 · Received February 4, 2021

    Report

    Report Number
    2134265-2021-01160
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 13, 2021
    Report Date
    February 4, 2021
    Manufacturer
    MODO INCORPORATED
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CART WHEELS ARE BROKEN. THE ACCOUNT REPORTED THAT ALL FOUR WHEELS TO THE CART ARE WEARING DUE TO USE. THIS CAUSES FRICTION MAKING THE CART HARD TO PUSH. DUE TO THIS, ONE WHEEL BROKE, WHICH CAUSED INSTABILITY AND RESULTED IN THE CART TIPPING ON TO A STAFF MEMBER. THE STAFF MEMBER SUSTAINED MINOR BRUISING. NO OTHER INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180112 UNIVERSAL CART (W/O UPS) STAND, INFUSION FOX MODO INCORPORATED 700-60101

    Patients

    Seq Age Sex Outcome Treatment
    1