BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ CCOMBO CONTINUOUS CARDIAC OUTPUT VIP CATHETER

    MDR report key: 2943659 · Received January 30, 2013

    Report

    Report Number
    2943659
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    CATHETER PASSED CALIBRATION IN THE PACK. UPON REMOVAL OF THE CATHETER FROM THE PACKAGE TO TEST THE BALLOON IT WAS NOTED THE BALLOON WOULD NOT PASSIVELY DEFLATE. WHEN ZEROING THE CATHETER IT WOULD NOT ZERO PROPOERLY. THE CATHETER WOULD READ HIGH PRESSURES OUTSIDE OF PATIENT. A NEW CATHETER WAS OBTAINED AND USED WITHOUT DIFFICULTY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40134 SWAN GANZ CCOMBO CONTINUOUS CARDIAC OUTPUT VIP CATHETER CATHETER DYG EDWARDS LIFESCIENCES * 59312634

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR