BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACSCUBE

    MDR report key: 5107971 · Received September 28, 2015

    Report

    Report Number
    3003341080-2015-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Manufacturer
    DATCARD SYSTEMS, INC
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INITIAL COMPLAINT FROM CUSTOMER WAS "UNABLE TO IMPORT". UPON FURTHER TROUBLESHOOTING WITH CUSTOMER, WHEN THEY IMPORT MULTIPLE STUDIES, SOME STUDIES MAY BE SENT WITH NON-UPDATED DATA. THIS CAN RESULT IN STUDIES BEING ATTACHED TO INCORRECT PATIENTS DUE TO MATCHING ACCESSION NUMBERS. EITHER A SOFTWARE MALFUNCTION OR A USER ERROR; TECH SUPPORT AND SOFTWARE QA UNABLE TO DUPLICATE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640512 PACSCUBE DIGITAL IMAGE COMMUNICATIONS DEVICE LMD DATCARD SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1