BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3010226 · Received March 14, 2013

    Report

    Report Number
    1525965-2013-00048
    Date Received
    March 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS PERFORMING PATIENT PROCEDURE AND REPORTED THAT AT THE START AND END OF THE PROCEDURE, WHEN UTILIZING THE MULTIFUNCTION FOOT SWITCH TO MOVE THE PATIENT INTO AND OUT OF THE GANTRY, THE PATIENT SUPPORT STOPPED PREMATURELY OR MOVED IN A DIFFERENT DIRECTION THAN DESIRED. THE MOTION STOPPED WHEN THE CUSTOMER RELEASED THE PEDALS ON THE FOOT SWITCH. THERE WAS NO REPORT OF ANY HARM TO A PATIENT OR OPERATOR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108362 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1