BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 2240748 · Received August 23, 2011

    Report

    Report Number
    2240748
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 23, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A HEART ATTACK DURING THE CRITICAL PART OF HIS HEART CATHETERIZATION. THE STENT WAS BEING DEPLOYED. THE X-RAY SYSTEM SUDDENLY STOPPED WORKING. ATTEMPTS TO REBOOT FAILED. THE PATIENT HAD TO BE MOVED TO A DIFFERENT ROOM RESULTING IN A 20 MINUTE DELAY IN HIS IMMEDIATE CARE.SYSTEM ERROR LOGS WERE REVIEWED AND ARE BEING SUBMITTED TO THE MANUFACTURER FOR FUTURE ANALYSIS. CAUSE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 X-RAY SYSTEM, CATH/ANGIO IZO GE MEDICAL SYSTEMS, LLC INNOVA 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention NO OTHER THERAPIES