BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS V3000

    MDR report key: 2033654 · Received February 11, 2011

    Report

    Report Number
    3003768277-2011-00145
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K910370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS A SPORADIC OVER CURRENT IN THE MOTOR OF THE COLLIMATOR, WHICH CAUSED A CIRCUIT BREAKER TO TRIP. THE FIELD SERVICE ENGINEER REPLACED THE SYSTEM PART, WHICH SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE FRONTAL COLLIMATOR NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS V3000 IZI PHILIPS HEALTHCARE 72243

    Patients

    Seq Age Sex Outcome Treatment
    1