BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNCARDIA COMPANION LI-POLYMER BATTERY PACK

    MDR report key: 2904458 · Received December 6, 2012

    Report

    Report Number
    3003761017-2012-00090
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 5, 2012
    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

    THIS COMPANION EXTERNAL BATTERY WAS NOT IN USE WITH A PT. THE CUSTOMER REPORTED THAT THE COMPANION EXTERNAL BATTERY WAS DEEPLY DEPLETED. SHE TRIED TO CHARGE THE BATTERY FOR SEVERAL HOURS WITHOUT SUCCESS. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PT BECAUSE THE ISSUE WAS OBSERVED WHEN THE BATTERY WAS NOT IN USE BY A PT. IN ADDITION, THE REPORTED ISSUE WOULD NOT PREVENT A COMPANION DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. COMPANION DRIVERS HAVE REDUNDANT SOURCES OF POWER. SYNCARDIA HAS REQUESTED THAT THE COMPANION EXTERNAL BATTERY 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 SNCARDIA COMPANION LI-POLYMER BATTERY PACK BATTERY LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1