BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HIGH DEFINITION LCD MONITOR

    MDR report key: 2240865 · Received August 4, 2011

    Report

    Report Number
    8010047-2011-00179
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOW-UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE COMPLETE LOSS OF IMAGE WAS EXPERIENCED TOWARD THE BEGINNING OF THE PROCEDURE AND THE INTENDED PROCEDURE WAS REPORTEDLY ABORTED. THE USER FACILITY REPORTED THAT THEY LATER OBTAINED A REPLACEMENT POWER SUPPLY, AND THE MONITOR WORKED APPROPRIATELY. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. BASED ON THE INFO REPORTED FROM THE USER FACILITY, THE REPORTED PHENOMENON APPEARED TO BE RELATED TO THE AC ADAPTOR. IF THE AC ADAPTOR IS RETURNED FOR EVAL AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH DEFINITION LCD MONITOR MONITOR FET OLYMPUS MEDICAL SYSTEM CORPORATION OEV-261H NA

    Patients

    Seq Age Sex Outcome Treatment
    1