BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10570081 · Received September 22, 2020

    Report

    Report Number
    8010047-2020-06741
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Report Date
    December 30, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. PROBABLE CAUSES THAT COULD HAVE LED TO THE REPORTED EVENT INCLUDE THAT THE BUTTON FOR SWITCHING THE INPUT SIGNAL WAS NOT SET CORRECTLY ACCORDING TO THE PROPOSED INFORMATION OR THAT THE IMAGE PROCESSING BOARD WAS TEMPORARY DEFECTIVE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THIS EVENT OCCURRED DURING THE BEGINNING OF AN UNSPECIFIED DIAGNOSTIC PROCEDURE. ALTHOUGH, OTHER DEVICES WERE INVOLVED IN THE EVENT, THE CUSTOMER WAS UNABLE TO PROVIDE THEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WAS A 10 MINUTE DELAY. THE MONITOR WAS INSPECTED AND NO ANOMALIES WERE OBSERVED. THE MONITOR CABLE WAS NOTED TO BE UNDAMAGED, CONNECTED PROPERLY AND SECURE. PER THE CUSTOMER, THE INSTRUCTIONS FOR USE ARE BEING FOLLOWED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE REPORTED EVENT COULD NOT BE DUPLICATED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME AS ALL SIGNALS FUNCTIONED NORMALLY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED NO VIDEO WAS BEING PRODUCED FROM THE UNIT. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033357 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1