BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA VISION

    MDR report key: 4252773 · Received November 6, 2014

    Report

    Report Number
    4252773
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 28, 2014
    Report Date
    November 6, 2014
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY LLC
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CYSTO TABLE MALFUNCTIONED, NO PICTURE ON THE MONITOR SCREEN. THE STAFF MEMBER IDENTIFIED A CONNECTION LOOSE AT THE BACK OF THE CABINET HOLDING THE COMPUTER. THE STAFF MEMBER REPORTED RAD/BIOMED WAS CALLED AND RECONNECTED THIS LOOSE CONNECTION. RAD/BIOMED RELOOK AT THIS CONNECTION AS IT WAS LOOSE AGAIN; HE CAME AND TOLD ME IT NEEDED A CLAMP APPLIED TO HOLD THE CONNECTIONS TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714855 HYDRA VISION TABLE, CYSTOMETRIC KQS LIEBEL-FLARSHEIM COMPANY LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *