BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE ICT

    MDR report key: 3433011 · Received October 18, 2013

    Report

    Report Number
    1525965-2013-00344
    Event Type
    Other
    Date Received
    October 18, 2013
    Report Date
    July 26, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(6) OF 2007. PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND FOUND THAT THIS ISSUE OCCURS WHEN THE COUCH TOP IS ALL THE WAY OUT TO THE OUTER LIMITS. THE COUCH TOP CONTACTS THE GANTRY EVENT WHEN NO WEIGHT IS APPLIED TO THE FOOT BOARD, BUT IT DOE NOT PRESS THE COVER INTO CONTACT WITH THE ROTATING FRAME UNLESS THERE IS WEIGHT ON IT. THE ROOT CAUSE OF THE FOOT BOARD HITTING THE GANTRY WHEN THE COUCH IS HOMED AND/OR PULLED ALL THE WAY OUT OF THE GANTRY WAS DETERMINED TO BE THAT THE FOOT BOARD WAS TOO LONG. THE FSE REPLACED THE ORIGINAL FOOTBOARD (B)(4), WHICH IS 1.96 INCHES SHORTER, SO IT DOES NOT CONTACT THE GANTRY WHEN COUCH IS LOWERED.(B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM A CUSTOMER SITE THAT WHEN THE PATIENT SUPPORT (COUCH) IS LOWERED ALL THE WAY DOWN, THE FOOT BOARD ON THE COUCH HITS THE GANTRY. IF A PATIENT IS ON THE COUCH TOP AND APPLIES WEIGHT ON THE FOOTBOARD IT PRESSES AGAINST THE GANTRY COVER ENOUGH TO MAKE THE GANTRY ROTATING PART HIT THE INSIDE OF COVER AND MAKE A KNOCKING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536141 BRILLIANCE ICT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1