BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IKVS STATIONARY DRIVING DEVICE

    MDR report key: 1410068 · Received June 12, 2009

    Report

    Report Number
    1410068
    Event Type
    Malfunction
    Date Received
    June 12, 2009
    Date of Event
    April 13, 2009
    Report Date
    May 11, 2009
    Manufacturer
    BERLIN HEART, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BERLIN HEART UNIT SHOULD HAVE AN OPERATING SYSTOLE PRESSURE OF 190MM/HG. DURING SHIFT CHANGE IT WAS NOTED THAT THE VALUE REGISTERED 217.5 MM/HG. THE OPERATING SYSTOLE PRESSURE WAS MANUALLY CHANGED TO 200MM/HG. APPROXIMATELY 28 HOURS LATER IT WAS NOTED THAT THE VALUE HAD DROPPED TO 190 MM/HG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IKVS STATIONARY DRIVING DEVICE VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR