BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 280

    MDR report key: 6914010 · Received October 4, 2017

    Report

    Report Number
    6914010
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 22, 2017
    Manufacturer
    MORTARA INSTRUMENTS INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WE HAVE 5 MOTARA EKG CARTS AND WE HAVE HAD THESE FOR 3 YEARS AND 4 MONTHS. ALL 5 HAD ISSUES WITH THE TOUCH SCREEN. IT IS DIFFICULT TO GET THE CART TO ACKNOWLEDGE WHEN YOU HAVE TOUCHED SOMETHING ON THE DISPLAY. MANUFACTURER RESPONSE FOR EKG CART, MORTARA (PER SITE REPORTER). THEY FEEL THAT MAYBE STAFF IS USING A PEN OR SOME FOREIGN OBJECT ON THE TOUCH SCREEN, BUT THERE ARE NO VISUAL MARKINGS ON THE TOUCH SCREENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693547 ELI 280 ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENTS INC. ELI 280

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES| TO DO A 12 LEAD EKG ON A PATIENT