BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10875015 · Received November 20, 2020

    Report

    Report Number
    8010047-2020-09217
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 AND DEVICE EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE 6 YEARS AND 2 MONTHS HAVE PASSED SINCE MANUFACTURE, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO AGING DEGRADATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION, THE USER¿S REQUEST WAS CONFIRMED DUE TO A QUANTUM BOARD (QB). A MINOR CRACK ON THE CORNER OF THE HOUSING WAS FOUND. NO OTHER ISSUES WERE FOUND DURING THE DEVICE INSPECTION. IF ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED IMAGE ISSUES ON A LIQUID CRYSTAL DISPLAY (LCD) MONITOR. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM OR INJURIES REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344004 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1