BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY G (FLOOR)-LARC-OMCP-VISUB-CCD

    MDR report key: 2093897 · Received April 19, 2011

    Report

    Report Number
    3003768277-2011-00343
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER ON SITE CONCLUDED THAT COLLIMATOR NEEDED REPLACEMENT. REPLACEMENT OF FRONTAL COLLIMATOR SOLVED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SYSTEM UNRELIABLE AND OCCASIONAL COLLIMATOR ERROR MESSAGES ON SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY G (FLOOR)-LARC-OMCP-VISUB-CCD IZI PHILIPS HEALTHCARE 72247

    Patients

    Seq Age Sex Outcome Treatment
    1