BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3221668 · Received July 1, 2013

    Report

    Report Number
    3003761017-2013-00068
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION 2 DRIVER AND COMPANION HOSPITAL CART WERE NOT IN USE WITH A PT. THE CUSTOMER REPORTED THAT COMPANION 2 DRIVER S/N (B)(4) (WITH COMPANION HOSPITAL CART S/N (B)(4)) DID NOT RECOGNIZE WALL POWER, AND THE DRIVER'S BATTERIES RAN DOWN. THE CUSTOMER ALSO REPORTED THAT THE DRIVER EXHIBITED EXTERNAL BATTERY ALARMS AND EMERGENCY BATTERY ALARMS. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION 2 DRIVER AND COMPANION HOSPITAL CART WERE NOT IN USE BY A PT. IN ADDITION, THE COMPANION 2 DRIVER EXHIBITED ALARMS, NOTIFYING THE USER THAT THE EXTERNAL BATTERIES AND INTERNAL EMERGENCY BATTERY WERE AT A LOW CHARGE. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA, AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297578 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1