BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11022786 · Received December 16, 2020

    Report

    Report Number
    8010047-2020-10493
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    March 16, 2020
    Report Date
    December 16, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OLYMPUS SALES REP WAS ONSITE AND CONFIRMED THE CUSTOMER'S COMPLAINT. THE SALES REP TEMPORARILY USED THE COMP OUT TO THE OEV-262H MONITOR AND THEN USED SDI TO THE SECONDARY MONITOR. BASED ON THE INVESTIGATION, THE EVENT POINTED OUT WAS ESTIMATED TO BE CAUSED BY THE MALFUNCTION OF THE BOARD FOR PROCESSING THE IMAGE SIGNALS. THE MONITOR WAS NOT RETURNED TO OLYMPUS FOR REPAIR.

    Description of Event or Problem · 1

    AN OLYMPUS SALES REP REPORTED THAT HE TRIED TO CONNECT THE SDI CABLE FROM THE OTV-S190 PROCESSOR TO THE SDI 1 AND THE SDI 2 PORTS ON THE OEV-262H MONITOR BUT WAS UNABLE TO GET AN IMAGE. THE SALES REP WAS ABLE TO GET AN IMAGE TO DISPLAY ON THE MONITOR WHEN USING THE COMP OUT TO THE VIDEO IN ON THE OEV-262H MONITOR. THIS DEVICE MALFUNCTION OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489718 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1