BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC

    MDR report key: 2220333 · Received August 16, 2011

    Report

    Report Number
    2220333
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 6, 2011
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN CLINIC FOR REGULAR OUTPATIENT VAD CLINIC VISIT. ATTEMPTED TO DOWNLOAD DATA FROM HMII SYSTEM CONTROLLER TO SYSTEM MONITOR. MESSAGE THAT DATA COULD NOT BE RETRIEVED. TRIED ALTERNATE PM AND PATIENT CABLE - UNABLE TO RETRIEVE DATA. CONTACTED THORATEC, WHO ADVISED CHANGING THE SYSTEM CONTROLLER. SYSTEM CONTROLLER CHANGED AND CONNECTED TO SYSTEM MONITOR. DATA FROM NEW SYSTEM CONTROLLER WAS RETRIEVED AND RECENT HISTORY WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC HMII LVAS DSQ THORATEC 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other