BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3944697 · Received July 18, 2014

    Report

    Report Number
    3007042319-2014-00748
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 18, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. THIS IS ONE OF TWO REPORTS (3007042319-2014-00417 AND 3007042319-2014-00748) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    APPROXIMATELY SIX MONTHS POST IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED A POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERIES AND CONTROLLER WERE REMOVED FROM THE PATIENT AND NEW BATTERIES AND CONTROLLER WERE SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. PRELIMINARY REVIEW OF THE LOG FILES REVEALED THAT THE PATIENT HAD EXPERIENCED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422698 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - CONTROLLER| (B)(4) - BATTERY| (B)(4) - BATTERY| (B)(4) - BATTERY