BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10216302 · Received July 1, 2020

    Report

    Report Number
    8010047-2020-03778
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    May 10, 2020
    Report Date
    October 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN; HOWEVER, THE FOLLOWING WAS SUPPOSED TO BE THE CAUSE. THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE SUBJECT DEVICE, IT WAS NOTED THAT THE POWER SUPPLY UNIT FAILED. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682227 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1