BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10604748 · Received September 30, 2020

    Report

    Report Number
    8010047-2020-07007
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 3, 2020
    Report Date
    January 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF OLYMPUS SINGAPORE, OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE POWER SUPPLY BOARD FAILURE AND/OR THE VIDEO SIGNAL PROCESSING BOARD FAILURE OF THE SUBJECT DEVICE DUE TO THE AGING DETERIORATION BECAUSE IT HAVE BEEN PASSED MORE THAN 5 YEARS SINCE MANUFACTURING THE SUBJECT DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE SUBJECT DEVICE WAS NOT POWERED UP AT THE PREPARATION FOR USE. THE BIOMEDICAL ENGINEER OF THE FACILITY TRIED TO CHANGE THE AC POWER CORD AND USE DIRECTLY THE POWER SUPPLY POINT, BUT IT DID NOT WORK. THE PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM. AT THE INCOMING INSPECTION FOR THE REPAIR, OLYMPUS SINGAPORE TOTALLY CHECKED THE SUBJECT DEVICE AND IDENTIFIED THE REPORTED PHENOMENON. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071095 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1