BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2000

    MDR report key: 1274545 · Received December 29, 2008

    Report

    Report Number
    9611343-2008-00073
    Event Type
    Death
    Date Received
    December 29, 2008
    Date of Event
    December 12, 2008
    Report Date
    December 29, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K993037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR EXAM, THE SYSTEM SUDDENLY SHUT DOWN. THE PATIENT WAS ON THE TABLE AND IN CARDIAC ARREST. THE HEALTH CARE PROFESSIONAL RESET THE MAIN POWER AND TRIED TO REBOOT THE SYSTEM TWICE. THE SYSTEM WORKED AFTER THE SECOND RESET. THE PATIENT EXPIRED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS 2356861

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death