BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER

    MDR report key: 7054846 · Received November 22, 2017

    Report

    Report Number
    3007042319-2017-04238
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    September 2, 2015
    Report Date
    November 22, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ONE CONTROLLER AC (CAC) ADAPTER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT COULD NOT BE CONFIRMED; THE CAC ADAPTER OPERATED AS EXPECTED DURING BENCH TESTING. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL. THE REPORTED EVENT COULD NOT BE CONFIRMED DURING TESTING; NO MECHANICAL ISSUES WERE FOUND DURING TESTING. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS, WHICH WAS IN RESPONSE TO AN UPDATE TO THE MDR DECISION CRITERIA. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER AC (CAC) ADAPTER DID NOT "CLICK" IN AND THAT IT DID NOT FIT WELL. THE CAC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833596 HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER AC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1430DE

    Patients

    Seq Age Sex Outcome Treatment
    1