BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3870314 · Received June 12, 2014

    Report

    Report Number
    3007042319-2014-00601
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER WAS RETURNED TO HEARTWARE FOR EVALUATION. THE REPORTED EVENT FOR LOW ALARM SOUND COULD NOT BE CONFIRMED. THE CONTROLLER PASSED FUNCTIONAL TESTING AND ACOUSTIC TESTING CONFIRMED THAT ALARM SOUND LEVELS WERE WITHIN SPECIFICATIONS. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Description of Event or Problem · 1

    AFTER APPROXIMATELY ONE MONTH ON HEARTWARE SYSTEM SUPPORT, THIS PATIENT REPORTED "MUFFLED" LOW PRIORITY ALARMS FROM HIS CONTROLLER. HE PRESENTED TO HIS CLINIC WHERE IT WAS CONFIRMED THAT ALARM VOLUME WAS FAINT AND AN ELECTIVE CONTROLLER EXCHANGE WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347434 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1