BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATOR SUPPORT SYSTEM CONSOLE

    MDR report key: 3841130 · Received February 26, 2014

    Report

    Report Number
    3003761017-2014-00034
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 25, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CIRCUIT BREAKER ON THE CSS CONSOLE INTERFACE PANEL TRIPPED UPON PLUGGING THE CSS CONSOLE INTO WALL POWER. THIS OCCURRED AFTER RETURNING TO THE PATIENT'S ROOM AFTER AN OUTING TO PHYSICAL REHABILITATION. THE CUSTOMER ALSO REPORTED THAT THIS OCCURRED OCCASIONALLY. THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP CSS CONSOLE WITHOUT ADVERSE IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117718 SYNCARDIA CIRCULATOR SUPPORT SYSTEM CONSOLE CIRCULATOR ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 14

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR