BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE ICT

    MDR report key: 3221815 · Received July 9, 2013

    Report

    Report Number
    1525965-2013-00193
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFORMATION THAT THE CUSTOMER REPORTED THAT THE CUSTOMER REPORTED THE TABLE SETS ITSELF ON TO THE GANTRY WHILE IT'S BEING LOWERED. THERE WAS NO REPORT OF HARM TO THE PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312517 BRILLIANCE ICT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1