BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION DRIVER CADDY

    MDR report key: 2954001 · Received January 15, 2013

    Report

    Report Number
    3003761017-2013-00011
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 11, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SYNCARDIA COMPANION DRIVER CADDY IS A SMALL CART WITH WHEELS INTO WHICH THE COMPANION 2 DRIVER DOCKS. IT IS DESIGNED TO FACILITATE MOBILITY OF STABLE PATIENTS WHILE IN THE HOSPITAL. THE CUSTOMER REPORTED THAT THE HANDLE OF THE COMPANION DRIVER CADDY WAS BROKEN. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION DRIVER CADDY 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
    22002 SYNCARDIA COMPANION DRIVER CADDY CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1