BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVIVO/MDE ESCORT LINK CENTRAL STATION

    MDR report key: 2370047 · Received October 18, 2011

    Report

    Report Number
    1051786-2011-00010
    Event Type
    Other
    Date Received
    October 18, 2011
    Report Date
    September 26, 2011
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DSI
    PMA / PMN Number
    K970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FILED A MEDWATCH REPORT ((B)(6)) AND REPORTED THAT THE DEVICE HAD MALFUNCTIONED. BECAUSE THE USER REPORTED THE INCIDENT AS A MALFUNCTION, THE DEVICE MFR IS FILING THIS REPORT TO DOCUMENT THE EVAL OUTCOME. PRINT OUTS OF THE CENTRAL STATION SCREEN PROVIDED BY THE USER WERE EVALUATED BY THE DEVICE MFR. EXAMINATION OF THE PRINT OUTS BY THE DEVICE MFR REVEALED THAT THE USER PROGRAMMED ALL THREE CENTRAL STATION TILES TO THE SAME CHANNEL ((B)(4)). AS A RESULT, THE CENTRAL STATION WAS DISPLAYING THE SAME PT DATA IN ALL 3 TILES AS OPPOSED TO DISPLAYING DATA FROM THE 3 INDIVIDUAL PTS. THE OUTCOME OF THIS EVAL WAS COMMUNICATED TO THE USER FACILITY'S RISK MANAGER. THE RISK MANAGER CLAIMED THAT THE USER TRAINING WOULD BE CONDUCTED AS A RESULT OF THIS INCIDENT. WE ARE NOT CONSIDERING THIS REPORT TO BE A MALFUNCTION OF THE DEVICE SINCE THE DEVICE PERFORMED AS EXPECTED BASED ON THE INACCURATE CHANNEL INFO ENTERED INTO THE DEVICE BY THE USER. ADDITIONALLY, THE DEVICE'S INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING WARNING IN SEVERAL LOCATIONS REGARDING THE POSSIBILITY OF CONFIGURING MULTIPLE PT TILES TO THE SAME TELEMETRY CHANNEL (PAGES II, 9 -8, 9 - 9, AND 10 - 1): WARNING IT IS POSSIBLE TO CONFIGURE TWO (2) PT TILES ON THE VISION CENTRAL STATION TO THE SAME TELEMETRY CHANNEL ID NUMBER AND ADMIT A DIFFERENT PT NAME FOR EACH OF THE TWO (2) PT TILES. TO AVOID CONFUSION, WHEN CONFIGURING A NEW TELEMETRY PT TILE, CONFIRM THAT THERE IS NOT A PT TILE ALREADY CONFIGURED TO THE TELEMETRY CHANNEL ID NUMBER THAT YOU ARE SELECTING FOR THE NEW PT TILE PRIOR TO ADMITTING THE PT TO THE VISION CENTRAL STATION. (B)(4) ISSUE ASSOCIATED WITH THE USE OF THE DEVICE IN TERMS OF INAPPROPRIATE AND FALSE CONTROL SETTING FOR THE DEVICE'S SPECIFIED OPERATION AND/OR INTENDED USE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO/MDE ESCORT LINK CENTRAL STATION DSI INVIVO CORPORATION 20500-16H

    Patients

    Seq Age Sex Outcome Treatment
    1