BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRASSIST

    MDR report key: 2651312 · Received September 16, 2009

    Report

    Report Number
    2651312
    Event Type
    Malfunction
    Date Received
    September 16, 2009
    Date of Event
    September 10, 2009
    Report Date
    September 14, 2009
    Manufacturer
    VENTRACOR, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EMERGENTLY ARRIVED TO OPERATING ROOM WITH VENTRASSIST DEVICE THAT HAD FAILED. PT CRITICALLY UNSTABLE, EMERGENT REPLACEMENT OF FAILED DEVICE. FAILED DEVICE REMOVED AND SENT TO RISK MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRASSIST NONE DSQ VENTRACOR, INC. S1418-100874

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR