BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE BIGBORE ONCOLOGY

    MDR report key: 2950415 · Received February 5, 2013

    Report

    Report Number
    1525965-2013-00015
    Date Received
    February 5, 2013
    Report Date
    January 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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 A REPORT THAT THE CUSTOMER REPORTED THAT WHEN LOWERING A PATIENT AND RELEASING THE BUTTON, THE COUCH FELL 2-4 INCHES AFTER THE RELEASE OF THE BUTTON. THERE WAS NO HARM TO THE PATIENT OR OPERATOR AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48742 BRILLIANCE BIGBORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1