BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE

    MDR report key: 1741217 · Received May 21, 2010

    Report

    Report Number
    1741217
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    March 3, 2010
    Report Date
    May 21, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    NCV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKEN TO THE EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) ROOM BY THE CIRCULATOR AND THE ANESTHESIOLOGIST. UPON ENTERING THE ROOM, THE CIRCULATOR NOTED THE ESWL LEAKING CLEAR FLUID ONTO THE FLOOR. THE ESWL TECH WAS NOTIFIED. THE DR AND THE CIRCULATOR RETURNED THE PT TO THE PREOPERATIVE AREA. THE SAFETY MEASURES WERE MAINTAINED. THE DR WAS NOTIFIED OF THE ESWL TABLE AND THE MD MADE THE DECISION TO ABORT THE CASE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE LITHOTRIPTER, GALLSTONE NCV GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR