BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE BIGBORE ONCOLOGY

    MDR report key: 3080517 · Received April 24, 2013

    Report

    Report Number
    1525965-2013-00093
    Date Received
    April 24, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER THAT THEY WERE PERFORMING LASER ALIGNMENT QA CHECKS ON THE CT SYSTEM UTILIZING A PHANTOM AND REPORTED THAT THE PATIENT SUPPORT DROVE IN THE UPWARD DIRECTION WITHOUT COMMAND. THE SYSTEM E-STOP OPENED AND ALL MOTION WAS STOPPED. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176749 BRILLANCE BIGBORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1