BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10498138 · Received September 5, 2020

    Report

    Report Number
    8010047-2020-06222
    Event Type
    Malfunction
    Date Received
    September 5, 2020
    Date of Event
    July 19, 2020
    Report Date
    November 5, 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. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OLYMPUS INDIA THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE POWER SUPPLY CIRCUIT BOARD AND/OR THE IMAGE PROCESSING CIRCUIT BOARD DUE TO THE NORMAL AGING DETERIORATION. 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 PREPARATION FOR USE OF THE SUBJECT DEVICE, THE SUBJECT DEVICE AUTOMATICALLY RESTARTED EVERY TWO-TO-THREE MINUTES AFTER THE TURNING ON THE SUBJECT DEVICE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE SUBJECT DEVICE TURNED OFF AUTOMATICALLY AFTER THE FIVE MINUTES FROM TURNING ON THE SUBJECT DEVICE DUE TO THE FAILURE OF THE ELECTRICAL CIRCUIT BOARD. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) ALSO FOUND THAT THE SDI INPUT/OUTPUT DID NOT FUNCTIONED DUE TO THE FAILURE OF THE ELECTRICAL CIRCUIT BOARD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962314 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1