BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    MDR report key: 261034 · Received February 2, 2000

    Report

    Report Number
    1220648-2000-00005
    Event Type
    Malfunction
    Date Received
    February 2, 2000
    Date of Event
    January 24, 2000
    Report Date
    February 2, 2000
    Manufacturer
    ABIOMED, INC.
    Product Code
    DSQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PT SUPPORT, THE CONSLE WENT INTO HIGH PRESSURE, LOW PRESSURE ALARM AND STOPPED. THE BACKUP SYSTEM WAS USED WITH NO PT PROBLEMS. THE CONSOLE WAS EXAMINED AND THE PROBLEM COULD NOT BE REPRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM CARDIAC ASSIST DEVICE DSQ ABIOMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *