BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALCON

    MDR report key: 6983114 · Received October 27, 2017

    Report

    Report Number
    6983114
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 17, 2017
    Manufacturer
    VIASONIX
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PARTICLE BOARD PANEL WHERE THE LCD MONITOR SITS ON SUDDENLY BECAME DISLODGED FROM THE BACK SIDE AND THEREFORE TILTED FORWARD. THE SONOGRAPHER WAS ALMOST HIT BY THE LCD MONITOR. PER REPORTER, THE MANUFACTURER HAS BEEN VERY RECEPTIVE. THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED THAT THE HOSPITAL REMEDIATED THE PROBLEM WITH A BETTER SOLUTION AND RETURNED THE UNIT TO SERVICE. THE REPRESENTATIVE REQUESTED PICTURES WHICH SHOWED THE SYSTEM PRIOR AND AFTER REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763547 FALCON MONITOR, PERIPHERAL JOP VIASONIX FALCON PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 N.A.