BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3911309 · Received July 2, 2014

    Report

    Report Number
    3007042319-2014-00689
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    TWO BATTERIES WERE RETURNED TO HEARTWARE FOR EVALUATION; THE BATTERIES WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE BATTERY PERFORMED PER SPECIFICATION. REVIEW AND ANALYSIS OF THE CONTROLLER LOG FILES DID NOT CONFIRM THE REPORTED POWER SWITCHING EVENT; HOWEVER, CONTROLLER LOGS REVEALED A CONTROLLER POWER UP AND ASSOCIATED MOTOR START EVENT LOGGED ON THE EVENT DATE INDICATING THAT BOTH POWER SOURCES WERE DISCONNECTED. (B)(4) PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING. BATTERY CELL TESTING REVEALED A CONSIDERABLE NOISE SIGNATURE INDICATING THAT THE FAILURE WAS DUE TO AN INTERNAL COMPONENT FAILURE. ANALYSIS REVEALED THAT THE BATTERY FAILED DUE TO A BATTERY CIRCUIT BOARD MALFUNCTION AND FAULTY ELECTRICAL COMPONENT. HOWEVER, THE ROOT CAUSE OF THE ELECTRICAL COMPONENT'S FAILURE CANNOT BE DETERMINED. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. WHILE THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED, THE MOST LIKELY CAUSE OF INTERMITTENT SWITCHING RESULTED FROM A FAULTY ELECTRICAL COMPONENTS. THIS IS ONE OF TWO REPORTS (3007042319-2014-00689 AND 00880) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE AND A HALF MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNEXPECTED BEHAVIOR OF HIS BATTERIES, INCLUDING "INTERMITTENT STOPPING." A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER APPROXIMATELY ONE WEEK PRIOR TO THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385779 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - BATTERY