BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 1181711 · Received September 30, 2008

    Report

    Report Number
    9611343-2008-00048
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 30, 2008
    Manufacturer
    GE MEDICAL SYSTEM SCS
    Product Code
    IZI
    PMA / PMN Number
    K993037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE THE USER RAISED THE TABLE UP AND WHEN IT STOPPED, THE TABLE FREE FELL DOWN TO THE LOWER LIMIT. NO INJURY HAS BEEN REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORTED 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 SYSTEM SCS

    Patients

    Seq Age Sex Outcome Treatment
    1