BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS BI-PLANE IMAGING SYSTEM

    MDR report key: 1183464 · Received September 20, 2008

    Report

    Report Number
    1183464
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    July 18, 2008
    Report Date
    September 20, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC CATHETERIZATION, THE TABLE MALFUNCTIONED AND THE DRAINAGE CATHETER WAS PLACED UNDER ECHO GUIDANCE. IT WAS DETERMINED THAT THE MOTORIZED MOVEMENT CONTROL FOR THE TABLE IN TILT MODE WAS NOT WORKING CORRECTLY. THE REST OF THE SYSTEM WAS WORKING CORRECTLY, EXCEPT FOR TILT MODE. ORDERED NEW GEOMETRY TSO PARTS AND INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS BI-PLANE IMAGING SYSTEM X-RAY SYSTEM, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS 300000407 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR