BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION EXTERNAL BATTERY

    MDR report key: 2891352 · Received November 29, 2012

    Report

    Report Number
    3003761017-2012-00084
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS COMPANION EXTERNAL BATTERY WAS NOT IN USE BY A PT. THE CUSTOMER AT (B)(4) REPORTED THAT THE COMPANION EXTERNAL BATTERY COULD NOT BE CHARGED. SEVERAL ATTEMPTS TO CHARGE THE BATTERY WERE UNSUCCESSFUL. THE COMPANION EXTERNAL BATTERY WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION EXTERNAL BATTERY BATTERY LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1