BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11256613 · Received January 31, 2021

    Report

    Report Number
    8010047-2021-02045
    Event Type
    Malfunction
    Date Received
    January 31, 2021
    Date of Event
    December 21, 2020
    Report Date
    April 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT AND CORRECT IN THE INITIAL REPORT SUBMITTED ON JAN 31, 2021. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. HOWEVER, BASED ON THE ADDITIONAL INFORMATION, OMSC CONCLUDED THAT THE REPORTED EVENT WAS NOT REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR 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 DURING THE UNSPECIFIED TIMING, THE IMAGE CONNECTED TO THE SERIAL DIGITAL INTERFACE INPUT CONNECTOR (SDI1) OF THE SUBJECT DEVICE WAS NOT DISPLAYED. IN THE EVALUATION OF OLYMPUS (B)(4) THE FOLLOWING WAS CONFIRMED, THERE WAS A FAILURE OF THE ELECTRICAL BOARD OF THE SUBJECT DEVICE AND NO SIGNAL WAS OUTPUT FROM SDI1. THERE WERE NO ABNORMALITIES IN THE OUTPUT SIGNALS OF OTHER CHANNELS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153121 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1