BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOOK AMP WITH SECONDLOOK DIGITAL GE

    MDR report key: 7183668 · Received January 11, 2018

    Report

    Report Number
    1225671-2018-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ICAD, INCORPORATED
    Product Code
    MYN
    UDI-DI
    00858012005014
    PMA / PMN Number
    P010038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE OEM FIELD SERVICE ENGINEER RETURNED TO CUSTOMER SITE AND INSTALLED THE CAD LICENSE AND THE SYSTEM IS WORKING PROPERLY.

    Description of Event or Problem · 1

    A CUSTOMER SITE INDICATED THAT NO CAD MARKINGS WERE REPORTED FROM THE CAD AFTER PROCESSING PATIENT IMAGES. THE OEM MAMMOGRAPHY FIELD SERVICE ENGINEER (FSE) DID NOT APPLY THE CAD LICENSE AFTER INSTALLING THE CAD SOFTWARE. THIS RESULTED IN THE SITE NOT HAVING CAD MARKS ON CASES FOR SOME TIME. NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27748 POWERLOOK AMP WITH SECONDLOOK DIGITAL GE SECONDLOOK DIGITAL MYN ICAD, INCORPORATED V7.2 00858012005014

    Patients

    Seq Age Sex Outcome Treatment
    1