BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7677626 · Received July 11, 2018

    Report

    Report Number
    3007042319-2018-02960
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 18, 2018
    Report Date
    November 29, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-11-30 UDI #: (B)(4), RETURN DATE: 2018-06-22, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-11-30 UDI #: (B)(4), RETURN DATE: 2018-06-22, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2016-11-30 UDI #: (B)(4), RETURN DATE: 2018-06-22 , DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-11-30 UDI #: (B)(4), RETURN DATE: 2018-06-22 , DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-11-30 UDI #: (B)(4) MFG DATE: 2015-11-30 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING. THE CHARGE ON THE BATTERIES WERE GREATER THAN OR EQUAL TO TWENTY FIVE PERCENT. THE SITE FURTHER REPORTED THAT THE PATIENT HEARD BEEPING DURING THESE EVENTS. ONE OF THE DEVICES IS STILL WITH THE CUSTOMER WHILE THE OTHER DEVICES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522187 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS UNKNOWN VAD