BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE 64 SLICE CT SCANNER

    MDR report key: 1002865 · Received February 12, 2008

    Report

    Report Number
    1525965-2008-00007
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 18, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS FILED ON 02/06/2008. THE PT WAS NOT AFFECTED BY THIS EVENT. THE COUCH TOP CLUTCH RELEASE FORCE WAS EVALUATED AND MET SPECIFICATIONS. IT WAS DECIDED TO INSTALL A NEW CLUTCH AS A PROACTIVE MEASURE. THE SYSTEM MEETS SPECIFICATIONS, OPERATES AS DESIGNED, AND IS IN CLINICAL USE. THE COUCH ATTACHED TO THE CT SYSTEM HAS A CLUTCH THAT IS INTENDED TO RELEASE IF A FORCE ABOVE ITS DESIGN LIMIT (65LBS) IS APPLIED. THE INTENT OF THIS DESIGN ELEMENT IS TO ENABLE A COUCH RELEASE FOR EMERGENCY EXTRACTIONS FROM THE SYSTEM. SLIDING A HEAVY PT DOWN THE COUCH CAN EXERT A FORCE GREATER THAN OR EQUAL TO THIS RELEASE LEVEL WHICH WILL ALLOW THE COUCH TO MOVE IN THE DIRECTION OF THAT FORCE, PER DESIGN.

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS POSITIONING A PT ON THE COUCH. PER LOCAL SITE PROCEDURE, THE PT WAS ON A SHEET ON TOP OF THE COUCH. THE TECHNOLOGIST STOOD BETWEEN THE COUCH AND GANTRY AND PULLED THE SHEET TOWARDS THE GANTRY TO POSITION THE PT. THE COUCH TOP CLUTCH RELEASED AS PER DESIGN, AND THE TECHNOLOGIST WAS PINNED BETWEEN THE COUCH AND THE GANTRY. THE TECHNOLOGIST WAS SENT TO THE EMPLOYEE HEALTH DEPT, WHERE SHE WAS EVALUATED. THE TECHNOLOGIST WAS TREATED WITH MUSCLE RELAXANTS. THE TECHNOLOGIST RETURNED TO WORK WITH NO LOST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 64 SLICE CT SCANNER COMPUTED TOMOGRAPY SCANNER JAK PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention