BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 5233706 · Received November 18, 2015

    Report

    Report Number
    3007042319-2015-03006
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    November 25, 2014
    Report Date
    November 28, 2014
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE (IFU), PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF POWER SOURCES. THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, VISUAL AND AUDIBLE ALARM MANAGEMENT, AND DEVICE MANAGEMENT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A POWER SOURCE MALFUNCTION. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES ARE OUTLINED. BASED ON THE RESULTS OF THE PREVIOUS MANUFACTURER'S INTERNAL INVESTIGATION (CAPA(B)(4)), FIELD ACTIONS (FSCA APR2014/2014.1) AND CHANGES TO THE BATTERY INTERNAL CELL SUPPLIER, NO ADDITIONAL INVESTIGATION OF THIS EVENT IS REQUIRED AT THIS TIME. THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO FAULTY INTERNAL CELLS WITHIN THE BATTERY PACK AS SUPPORTED BY (B)(4).

    Description of Event or Problem · 1

    THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR REPORTED THE BATTERY HAD AN INADEQUATE POWER CHARGE. THE BATTERY WAS EXCHANGED FOR ONE FROM STOCK. THERE WAS NO EFFECT ON THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763812 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1