BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMTEC-ARENA TTA2

    MDR report key: 9328104 · Received November 15, 2019

    Report

    Report Number
    8043836-2019-00003
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 20, 2019
    Manufacturer
    TOMTEC IMAGING SYSTEMS GMBH
    Product Code
    LLZ
    UDI-DI
    04260361440143
    PMA / PMN Number
    K150122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING TOMTEC-ARENA ZERO IF TWO TABS ARE OPEN ON THE BROWSER AT THE SAME TIME, IF THE USER SWITCHES FROM ONE TAB TO THE OTHER, THEN THE PATIENT INFORMATION FROM THE FIRST TAB IS COPIED TO THE PATIENT STUDY ON THE SECOND TAB.TO DATE NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING TOMTEC-ARENA ZERO IF TWO TABS ARE OPEN ON THE BROWSER AT THE SAME TIME, IF THE USER SWITCHES FROM ONE TAB TO THE OTHER, THEN THE PATIENT INFORMATION FROM THE FIRST TAB IS COPIED TO THE PATIENT STUDY ON THE SECOND TAB.TO DATE NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121260 TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE LLZ TOMTEC IMAGING SYSTEMS GMBH TTA2 31.00 04260361440143

    Patients

    Seq Age Sex Outcome Treatment
    1