BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCE

    MDR report key: 2100907 · Received May 18, 2011

    Report

    Report Number
    MW5020663
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCE
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUR ANESTHESIOLOGIST, DR. (B)(6) WAS PLACING A SWAN GANZ IN THIS PT AND WAS HAVING DIFFICULTY INFLATING THE BALLOON. DR. (B)(6) STATED THAT WHEN HE PLACED THE CATHETER IT STARTED MALFUNCTIONING AND WAS NOT SURE IF HE WAS IN TOO FAR AND THAT THE BALLOON WOULD NOT INFLATE PROPERLY. THERE WAS NO HARM TO THE PT BECAUSE THE CATHETER WAS PULLED OUT OF THE PT. EDWARDS LIFESCIENCE WAS NOTIFIED AND IS SENDING A BOX TO SEND DEFECTIVE CATHETERS BACK TO COMPANY AND I REQUESTED A REPORT SENT TO ME AND WILL FORWARD TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCE SWAN GANZ LATEX FREE DYG EDWARDS LIFESCIENCE 58716215

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR