BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2100

    MDR report key: 1041036 · Received May 9, 2008

    Report

    Report Number
    9611343-2008-00028
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 9, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNOVA 2100 STOPPED DURING AN EMERGENCY STENT PROCEDURE. NO ERROR MESSAGES WERE PROVIDED. A PT DEATH WAS REPORTED. 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 2100 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death