BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2000 POSITIONER

    MDR report key: 560299 · Received December 17, 2004

    Report

    Report Number
    9611343-2004-00028
    Event Type
    Death
    Date Received
    December 17, 2004
    Date of Event
    October 14, 2004
    Report Date
    December 17, 2004
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SCHEDULED INTERVENTIONAL CARDIAC PROCEDURE THE PT DEVELOPED A PERFORATED VESSEL. WHILE THE SITUATION WAS BEING ATTENDED THE SYSTEM LOST POWER AND CEASED WORKING. APPROX FIFTEEN MINUTES ELAPSED BEFORE POWER WAS RESTORED AND THE SYSTEM RETURNED TO OPERATION. IT WAS REPORTED THAT THE PT DID NOT SURVIVE THE PERFORATED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 POSITIONER DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS EUROPE 2355746 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death