BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION EXTERNAL BATTERY

    MDR report key: 2883459 · Received November 14, 2012

    Report

    Report Number
    3003761017-2012-00080
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION EXTERNAL BATTERY WAS NOT IN USE WITH A PATIENT. A SYNCARDIA CLINICAL SUPPORT REPRESENTATIVE REPORTED THAT A SYNCARDIA COMPANION EXTERNAL BATTERY WOULD NOT CHARGE BEYOND 80 PERCENT DESPITE ATTEMPTS TO CHARGE IT IN TWO DIFFERENT CLINICAL COMPANION 2 DRIVERS. THIS ALLEGED FAILURE MDE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE BATTERY WAS NOT IN USE BY A PATIENT. IN ADDITION, THE REPORTED ISSUE WOULD NOT PREVENT A COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. COMPANION 2 DRIVERS HAVE REDUNDANT POWER SOURCES. THE COMPANION 2 EXTERNAL BATTERY 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
    1 SYNCARDIA COMPANION EXTERNAL BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1