BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2100 MONITORING SYSTEM

    MDR report key: 1052133 · Received May 22, 2008

    Report

    Report Number
    MW5007014
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 22, 2008
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2008 AT 1322 DURING AN EMERGENT PCI THE MOUSE AND KEYBOARD MONITORING SYSTEM FROZE, DISABLING THE FLUORO SYSTEM. AT 1325 A REBOOT WAS PERFORMED SUCCESSFULLY AND THE CASE PROCEEDED. AT 1355 ALL INNOVA SCREENS WENT BLACK, DISABLING FLUORO AND ALL TABLE FUNCTIONS. A POWERED DOWN REBOOT WAS PERFORMED. THE SYSTEM CAME BACK APPROXIMATELY 10 MINUTES LATER. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. THE ROOM WAS TAKEN OUT OF SERVICE AND GE WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100 MONITORING SYSTEM MONITORING DEVICE IZI GENERAL ELECTRIC INNOVA 2100

    Patients

    Seq Age Sex Outcome Treatment
    1