BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACSCUBE

    MDR report key: 5944662 · Received September 12, 2016

    Report

    Report Number
    3003341080-2016-00002
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 12, 2016
    Manufacturer
    DATCARD SYSTEMS, INC
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DISPOSED OF MONITOR.

    Description of Event or Problem · 1

    MONITOR INITIALLY DISPLAYED ABNORMAL FLICKERING THEN CAME SMELL LIKE SOMETHING WAS BURNING AND THEN VIEWED SMOKE COMING FROM THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595791 PACSCUBE DIGITAL IMAGE COMMUNICATIONS DEVICE LMD DATCARD SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1