BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACSCUBE

    MDR report key: 6786598 · Received August 10, 2017

    Report

    Report Number
    3003341080-2017-00001
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 11, 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 ROBOTIC WAS SMOKING. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567174 PACSCUBE MEDICAL IMAGE COMMUNICATIONS DEVICE LMD DATCARD SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1