BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3823160 · Received May 20, 2014

    Report

    Report Number
    3823160
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 12, 2014
    Report Date
    May 20, 2014
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ADJUSTING THE CLOCK ON THE SYSTEM MONITOR DUE TO DAYLIGHT SAVINGS TIME, THE NURSE HIT THE "SYNCH BUTTON" TO SYNCHRONIZE THE MONITOR AND THE CONTROLLER CLOCKS AND AN ALARM OCCURRED AS FOLLOWS..."CHANGE SYSTEM CONTROLLER, CHANGE BACKUP BATTERY OR SIMILAR". THE PUMP/CONTROLLER CONTINUED TO OPERATE WITHOUT PROBLEMS. THE ALARM COULD NOT BE RESOLVED WITHOUT REPLACING THE CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300290 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC * 105109

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR