BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10589268 · Received September 25, 2020

    Report

    Report Number
    8010047-2020-06885
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 31, 2020
    Report Date
    January 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE XENON LAMP WAS REPLACED IN THE FIELD WHICH RESOLVED THE ISSUE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE MONITOR SCREEN WENT BLACK, ALONG WITH THE SCOPE IMAGE AS MAIN LAMP SWITCHED OVER TO THE SPARE LAMP. THE CUSTOMER TURNED THE LIGHT SOURCE OFF AND ON TO NO AVAIL, AS THE MAIN LAMP WOULD NOT STAY ON. THE PROCEDURE WAS COMPLETED AS INTENDED. THE LAMP IS TO BE REPORTED UNDER ANOTHER MFR. REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053105 HIGH DEFINITION LCD MONITOR MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV261H

    Patients

    Seq Age Sex Outcome Treatment
    1