BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3130021 · Received May 24, 2013

    Report

    Report Number
    3007042319-2013-00077
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE CONTROLLER WAS RETURNED TO HEARTWARE; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THESE INCLUDED CLINICAL EVENT, VISUAL & FUNCTIONAL TESTING AND REVIEW OF CONTROLLER LOG FILES. VISUAL EXAMINATION REVEALED NO SIGN OF PHYSICAL DAMAGE. THE EVENT "LOW SOUND" WAS CONFIRMED DURING FUNCTIONAL TESTING. LOUDNESS AND PITCH OF ALL AUDIBLE ALARMS WERE VERY LOW COMPARED TO OTHER TEST-BED CONTROLLERS. ADDITIONALLY, THE CONTROLLER HOUSING AND SPEAKER WERE CAREFULLY EXAMINED AND A SIGNIFICANT AMOUNT OF DUST PARTICLES WAS IDENTIFIED INSIDE THE CONTROLLER, COVERING THE BACK OF THE SPEAKER. ADDITIONALLY, SOME DAMAGE WAS NOTED TO THE CONTROLLER CASE SEAL. THE CAUSE FOR THE LOW SOUND WAS A DEFECTIVE SPEAKER RELATED TO THE CONTAMINATION IDENTIFIED ON THE SPEAKER. THE CAUSE OF THE CONTAMINATION INSIDE THE CONTROLLER CANNOT BE DETERMINED, BUT IT IS LIKELY RELATED TO THE DAMAGED GASKET ON THE CONTROLLER CASE. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT DURING THE PATIENT¿S ROUTINE VISIT, HE STATED THAT WHEN HE EXPERIENCED AN ALARM, THE SOUND WAS VERY LOW. THE VAD COORDINATOR WAS ABLE TO REPRODUCE AN ALARM AND CONFIRMED THAT THE ALARM VOLUME SEEMED LOW. FOR THIS REASON, THE CONTROLLER WAS EXCHANGED. THE EVENT WAS RESOLVED WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231227 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1