BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3871352 · Received June 13, 2014

    Report

    Report Number
    3007042319-2014-00610
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    February 20, 2014
    Report Date
    May 15, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT, MFR # 3007042319-2014-00610, WAS ENTERED AS A DUPLICATE FROM MFR # 3007042319-2015-04143. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN LOSS OF POWER RESULTING IN A PUMP STOP FOR APPROXIMATELY 30 SECONDS. AS A PRECAUTIONARY MEASURE, THE PATIENT WAS DIRECTED TO EXCHANGE THE CONTROLLER. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLICATIONS DURING THIS EVENT. FOLLOWING THE EVENT, THE PATIENT ARRIVED AT THE HOSPITAL FOR EVALUATION. A PRELIMINARY REVIEW OF THE LOG FILES REVEALED A "CONTROLLER POWER-UP" AND SUBSEQUENT "MOTOR START" EVENT ON THE DATE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350967 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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