BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3007563 · Received March 15, 2013

    Report

    Report Number
    3007563
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 16, 2011
    Report Date
    March 14, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FREEDOM DRIVER WAS MAKING A SQUEAKY NOISE. THE PATIENT REMAINED STABLE BUT WAS INSTRUCTED TO COME TO (B)(6) TO CHANGE OUT THE DEVICE. THE FREEDOM DRIVER WAS SWITCHED WITHOUT INCIDENT. THE FAILURE INVESTIGATION REVEALED A BROKEN FAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109936 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1