BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 585570 · Received March 7, 2005

    Report

    Report Number
    585570
    Event Type
    Malfunction
    Date Received
    March 7, 2005
    Date of Event
    February 22, 2005
    Report Date
    March 7, 2005
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS HAVING AN INTERVENTION DONE BY THE CARDIOLOGIST. IT WAS ALMOST FINISHED WHEN AN ERROR MESSAGE CAME UP ON THE EQUIPMENT MONITOR. THE STAFF TRIED TO REBOOT THE SYSTEM TWICE AND IT DID NOT RESPOND. AT THAT TIME WE NOTIFIED BIOMED OF THE PROBLEM. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM AND COMPLETED THE INTERVENTION WITH NO COMPLICATION. SERVICE WAS CALLED IN AND IT WAS FOUND THAT THE X-RAY TUBE HAD BLOWN AND ONE WAS ORDERED AND INSTALLED. GENERAL ELECTRIC COMPANY HAS NO SET TIME FOR THE TUBE REPLACEMENT. NORMAL TUBE REPLACEMENT IS THREE-FIVE YEARS. THERE WAS NO INDICATION THAT THE TUBE WAS GOING BAD PRIOR TO THE START OF THE CASE. THERE WAS A NORMAL START UP WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 X-RAY EQUIPMENT MQB GE MEDICAL SYSTEMS, LLC INNOVA 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR