BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10395261 · Received August 12, 2020

    Report

    Report Number
    8010047-2020-05446
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 16, 2020
    Report Date
    September 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, THEREFORE OMSC COULD NOT INVESTIGATE THE SUBJECT DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT BASED UPON THE INFORMATION FROM OLYMPUS INDIA, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE ACCIDENTAL FAILURE OF POWER SUPPLY BOARD OF THE SUBJECT DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    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 THAT DURING A PREPARATION FOR AN UNSPECIFIED PROCEDURE WITH THE SUBJECT DEVICE AT THE USER FACILITY, THE SUBJECT DEVICE WAS POWERED OFF AUTOMATICALLY AFTER APPROXIMATELY FIVE TO TEN MINUTES. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION. OLYMPUS MEDICAL SYSTEMS INDIA CHECKED THE SUBJECT DEVICE AND IT WAS FOUND THAT THE REPORTED PHENOMENON DUE TO THE FAILURE OF POWER SUPPLY BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861882 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1