BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MX 8000 CT

    MDR report key: 1916551 · Received November 23, 2010

    Report

    Report Number
    MW5018349
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    August 15, 2010
    Report Date
    November 23, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF PHILIPS HEALTHCARE TO PROVIDE (B)(4) DOCUMENTATION UPON REQUEST BY A HEALTHCARE PROFESSIONAL. SINCE (B)(6) 2010, I HAVE RECEIVED NO RESPONSE FOR COMPLAINT MATERIALS FOR THE MX8000 CT. I HAVE SENT NUMEROUS REQUEST TO THE PROPER COMPLIANCE OFFICERS INCLUDING (B)(4). FAILURE TO PROVIDE THESE MATERIALS IS CREATING THE ENVIRONMENT FOR EXCESSIVE RADIATION DOSES TO PTS IN A CLINICAL SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX 8000 CT COMPUTERISED AXIAL TOMOGRAPHY JAK PHILIPS HEALTHCARE MX 8000

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R