BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 13435247 · Received February 3, 2022

    Report

    Report Number
    8010047-2022-02345
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 5, 2022
    Report Date
    April 25, 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
    VM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION FOUND THE MONITOR TURNS OFF POWER AUTOMATICALLY AFTER TURNING ON SOME MINUTES DUE TO A DEFECTIVE POWER SUPPLY BOARD. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE CAUSE OF THE DEFECTIVE POWER SUPPLY BOARD COULD NOT BE IDENTIFIED. NO DEFECT INSIDE THE DEVICE OTHER THAN THE PHENOMENON POINTED OUT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS (OVN) TECHNICAL SERVICE ENGINEER BECAME AWARE THAT THE ASSET HIGH DEFINITION LIQUID CRYSTAL DISPLAY MONITOR ¿DID NOT POWER UP WHEN INSPECTED BEFORE DELIVERING TO DEMONSTRATION." NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812786 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown