BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE INNOVA CATH LAB

    MDR report key: 518851 · Received March 19, 2004

    Report

    Report Number
    MW1031600
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Date of Event
    February 17, 2004
    Report Date
    March 16, 2004
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GE INNOVA CATH SYSTEM SHUT OFF DURING PROCEDURE AND REQUIRED 10 MINUTES TO RESTART. SHUT OFF WAS DUE TO AIR BUBB/FLUID LEVEL IN CHILLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE INNOVA CATH LAB X-RAY EQUIPMENT IZO GENERAL ELECTRIC INNOVA 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other