BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 4022979 · Received January 17, 2014

    Report

    Report Number
    4022979
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 17, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR A CARDIAC CATHETERIZATION. A CATHETER WAS INTRODUCED FOR ANGIOGRAPHY. WHEN MD STEPPED ON THE PEDAL FOR FLUOROSCOPY, THE X-RAY "WENT DOWN" AND THE SCREEN WAS BLANK. A SOFT RE-BOOT WHICH TAKES APPROXIMATELY 30 SECONDS, WAS ATTEMPTED. WHEN THAT WAS NOT SUCCESSFUL, THE TECH COMPLETED A HARD REBOOT WHICH TAKES 4-5 MINUTES FOR THE SCREENS TO FULLY COME UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46190 INNOVA 2000 SYSTEM, X-RAY OWB GE MEDICAL SYSTEMS, LLC GENERATOR GE 2131100-3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR