BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIP PLUS

    MDR report key: 1051505 · Received April 28, 2008

    Report

    Report Number
    1051505
    Event Type
    Malfunction
    Date Received
    April 28, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 28, 2008
    Manufacturer
    EDWARD LIFESCIENCES, LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PRE CHECK OF THE SWAN GANZ CATHETER # 834HF75; DETERMINED THAT IT WAS WORKING PROPERLY BEFORE INSERTION. AFTER INSERTED THE BALLOON WOULD NOT WORK PROPERLY. ONCE THE CATHETER WAS REMOVED IT WAS NO LONGER WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIP PLUS CATHETER, PULMONARY ARTERY DYG EDWARD LIFESCIENCES, LLC * 237AC898

    Patients

    Seq Age Sex Outcome Treatment
    1 *