BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10507475 · Received September 9, 2020

    Report

    Report Number
    8010047-2020-06337
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    March 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE FOLLOWING SECTIONS WERE UPDATED: D4, G3, G6, H2, H4, H6, H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. AFTER FURTHER INVESTIGATION, THE EVENT WAS LIKELY CAUSED BY AN ACCIDENTAL FAILURE OF THE POWER SUPPLY UNIT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE TREND ANALYSIS AND INVESTIGATION CONCLUSION. THE ROOT CAUSE OF THE REPORTED ISSUE WAS NOT IDENTIFIED. A PROBABLE CAUSE COULD BE DUE TO THE INTERNAL CIRCUIT BOARD MALFUNCTIONED TEMPORARILY. THE EVENT OCCURRED DUE TO IMPACT, OTHER FACTORS OUTSIDE THE PRODUCT. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE USER FACILITY REPORT COULD NOT BE DUPLICATED DURING TESTING. TESTING RESULTS DID REVEAL RUST AND CORROSION, FRONT AND BACK COVER DAMAGE AND SCRATCHES ON THE SCREEN HOWEVER; THE MONITOR PASSED ALL FUNCTIONAL TESTING. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE MONITOR HAS POWER PROBLEMS. IT WAS REPORTED THAT THE MONITOR IS TURNING ON AND OFF EVERY COUPLE MINUTES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973988 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1