BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10566654 · Received September 22, 2020

    Report

    Report Number
    8010047-2020-06723
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 12, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AS THE ISSUE OF NO IMAGE WAS RESOLVED BY TROUBLESHOOTING; THE CABLE TO BE PLACED IN THE INPUTS OF THE WIRE CABLE WAS CONNECTED TO THE OUTPUT TERMINALS OF THE MONITOR. THERE WAS NO DEVICE MALFUNCTION. MANUFACTURE DATE IS AVAILABLE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT WAS NOT CONFIRMED. THE TECHNICAL ASSISTANCE CENTER (TAC) TECHNICIAN ATTEMPTED TO PROVIDED TROUBLESHOOTING WITH THE USER OVER THE PHONE. THE TECHNICIAN WAS INFORMED THAT THE INPUT SDI CABLE CONNECTED TO THE WIRELESS TRANSMITTER WAS NOT CONNECT TO A LIVE OUTPUT PORT ON THE MONITOR. SOMEHOW THE INPUT WIRE TO THE WIRELESS TRANSMITTER WAS CONNECTED TO THE OUTPUT PORT OF THE OEV-262H THAT DID NOT HAVE AN INPUT SDI CABLE CONNECTED TO IT. WHEN THE WIRE WAS CONNECTED TO AN OUTPUT PORT THAT HAD AN SDI INPUT, THE SIGNAL TO THE WIRELESS TRANSMITTER WAS ABLE SEND A VIDEO IMAGE TO THE OEV-262H ON THE ROLL STAND. THE MONITOR IS NOW OPERATING AS INTENDED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE IS NO IMAGE ON THE WIRELESS MONITOR. THIS EVENT OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030410 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1