BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY IQ CUSTOM INTEGRATION SYSTEM

    MDR report key: 4232424 · Received November 6, 2014

    Report

    Report Number
    1000404456-2014-00011
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    November 6, 2014
    Manufacturer
    VTS MEDICAL SYSTEMS
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED AND TESTED THE INTEGRATION SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE TECHNICIAN PERFORMED THE NECESSARY REPAIRS, TESTED THE SYSTEM AND PLACED IT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TOUCH PANEL AND FIELD MONITORS WERE DISPLAYING IMAGES FROM THE NURSE'S PERSONAL COMPUTER. NO INJURIES WERE REPORTED HOWEVER, A PROCEDURAL DELAY OCCURRED DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715851 HARMONY IQ CUSTOM INTEGRATION SYSTEM INTEGRATION SYSTEM LMD VTS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1