BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 13904620 · Received March 25, 2022

    Report

    Report Number
    8010047-2022-05037
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Report Date
    April 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED, UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, THE FOLLOWING DEFECTS WERE FOUND, FAULTY AC/DC POWER SUPPLY, NO IMAGE/LCD FAILURE, AND PRINTED-CIRCUIT BOARD FAILURE. THE FAULTY PARTS WERE REPLACED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 18FEB2022. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATE IN SECTION H4. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION CONFIRMED THAT THE DEVICE POWER FAILED TO TURN ON, LIKELY DUE TO A FAULTY GI BOARD. THE SPECIFIC ROOT CAUSE OF THE FAULTY GI BOARD COULD NOT BE DETERMINED AT THIS TIME. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    BASED ON AN INSPECTION OF AN OLYMPUS ASSET DEVICE (HIGH DEFINITION LCD MONITOR) IT WAS NOTED THAT THE UNIT DID NOT HAVE AN AC POWER, AND HAD DEAD PIXELS ON SCREEN. NO PATIENT AND USER INJURY REPORTED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE EVENT FOUND DURING THE EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054811 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown