BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR/C-STANDFLOOR-OMCP-VISUB-CCD(V5000)

    MDR report key: 2020571 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00141
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 4/11/2011.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT "IN THE MIDDLE OF THE CASE SYSTEM STOPPED FLUOROSCOPY AND WOULDN'T REBOOT. TYPICALLY IN THE MORNINGS AT START UP CUSTOMER REPORTS THERE IS A ERROR MESSAGE IMAGE SYSTEM NOT AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR/C-STANDFLOOR-OMCP-VISUB-CCD(V5000) IZI PHILIPS HEALTHCARE 72248

    Patients

    Seq Age Sex Outcome Treatment
    1