BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10706653 · Received October 20, 2020

    Report

    Report Number
    8010047-2020-07908
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 20, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE TECHNICAL ASSISTANCE CENTER (TAC) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. TAC REPORTED THAT THE CUSTOMER WAS USING SDI OUTPUT TO THE OEV-262H AND ALSO DVI TO NCARE, BOTH IMAGES REPORTED TOO LARGE. TAC HAD THE USER CHANGE SCAN SIZES IN THE OEV-262H FOR SDI AND DVI ACCORDING TO THE CUSTOMER THIS DID NOT CHANGE THE DISPLAYED IMAGE SIZE. THE LOCAL SALES REPRESENTATIVE WILL VISIT THE CUSTOMER¿S SITE TO ASSIST. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. IF THE ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED AT A LATER THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT THE IMAGE ON THE LCD MONITOR WAS TOO LARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171841 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1