BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORDICTUMOREX

    MDR report key: 4218913 · Received September 24, 2014

    Report

    Report Number
    3006738448-2014-00003
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 23, 2014
    Manufacturer
    NORDICNEUROLAB AS
    Product Code
    LLZ
    PMA / PMN Number
    K123306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING DEVELOPMENT OF NORDICBRAINEX V2.1, DATASETS THAT CAN GIVE RISE TO THE DESCRIBED SCENARIO ARE BLOCKED UPON LOADING. FOR NORDICTUMOREX, ALL CUSTOMERS HAVE BEEN INFORMED AND WHERE POSSIBLE ENCOURAGED TO CHANGE TO NORDICBRAINEX. OTHERWISE WE HAVE RECOMMENDED TO EVALUATE THE DICOM DATA USED FOR CLINICAL PURPOSE TO MAKE SURE THAT THEY ARE NOT CONFIGURED IN A WAY THAT TRIGGERS THIS BUG.

    Description of Event or Problem · 1

    A BUG WAS DISCOVERED DURING TESTING INTERNALLY IN THE MFR COMPANY. THE BUG WAS EVALUATED TO HAVE A PT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593383 NORDICTUMOREX PACS LLZ NORDICNEUROLAB AS

    Patients

    Seq Age Sex Outcome Treatment
    1