BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3821351 · Received April 28, 2014

    Report

    Report Number
    3003761017-2014-00059
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT WAS OBSERVED WHEN THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PT. IN ADDITION, THE REPORTED ISSUE WOULD NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS REDUNDANT ALTERNATE POWER SOURCES OF EXTERNAL BATTERIES AND WALL POWER. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA, AND THE RESULT WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THIS COMPANION 2 DRIVER WAS NOT SUPPORTING A PT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER THAT WAS IN STOCK AT THE IMPLANT CENTER HAD A "DEAD EMERGENCY BATTERY." THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER HAD NOT BEEN PLUGGED INTO EXTERNAL WALL POWER AT THE IMPLANT CENTER. THE CUSTOMER ALSO REPORTED THAT THE IMPLANT CENTER THEN ATTEMPTED TO CHARGE THE EMERGENCY BATTERY FOR ABOUT A WEEK BUT THE EMERGENCY BATTERY WOULD NOT CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254534 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1