BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACSCUBE

    MDR report key: 6853934 · Received September 8, 2017

    Report

    Report Number
    3003341080-2017-00002
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    DATCARD SYSTEMS, INC.
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT UNIT HAD SMELL OF BURNING PLASTIC. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633731 PACSCUBE MEDICAL IMAGE COMMUNICATIONS DEVICE LMD DATCARD SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1