BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY IQ 2800 INTEGRATION SYSTEM

    MDR report key: 4922914 · Received July 17, 2015

    Report

    Report Number
    1000404456-2015-00006
    Date Received
    July 17, 2015
    Date of Event
    April 24, 2015
    Report Date
    July 17, 2015
    Manufacturer
    VTS MEDICAL SYSTEMS
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER INTERVIEWED MULTIPLE USER FACILITY CLINICAL ENGINEERING AND BIOMEDICAL PERSONNEL AND IDENTIFIED THAT THE HARMONY IQ INTEGRATION SYSTEM WAS OPERATING PROPERLY WITH THE EXCEPTION OF AN INTERMITTENT ISSUE WITH THE VIDEO QUALITY FROM A NON-STERIS CAMERA TO A MONITOR. THE STERIS ACCOUNT MANAGER AND THE CAMERA MANUFACTURER'S ACCOUNT MANAGER REVIEWED THE INTEGRATION SYSTEM, MONITOR, AND CAMERA AND IDENTIFIED THAT THE MONITOR SETTINGS WERE INCORRECT. THESE SETTINGS CAN BE ADJUSTED BY USER FACILITY PERSONNEL. THE ACCOUNT MANAGERS RESET THE MONITORING SETTINGS AND ADVISED THE HOSPITAL BIOMEDICAL STAFF OF THE PROPER SETTINGS. A STERIS SERVICE TECHNICIAN ALSO INSPECTED THE HARMONY IQ INTEGRATION SYSTEM, PERFORMED A FULL FUNCTIONAL TEST OF THE UNIT, AND FOUND THE SYSTEM TO BE OPERATING ACCORDING TO SPECIFICATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE HARMONY IQ INTEGRATION SYSTEM WAS INSTALLED BY STERIS ON (B)(6) 2013. IT IS NOT UNDER STERIS SERVICE CONTRACT FOR MAINTENANCE.

    Description of Event or Problem · 1

    REFERENCE USER FACILITY MEDWATCH (B)(4). THE USER FACILITY REPORTED THAT THE CONTROL PANEL ON THEIR HARMONY IQ 2800 INTEGRATION SYSTEM WAS NOT OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466590 HARMONY IQ 2800 INTEGRATION SYSTEM INTEGRATION SYSTEM KQM VTS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other