BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEDENCE 6 SLICE

    MDR report key: 3124267 · Received May 16, 2013

    Report

    Report Number
    1525965-2013-00127
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Report Date
    April 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K041218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO PERFORM A COLLISION SENSITIVITY TEST AND UPON INVESTIGATION, IT WAS DISCOVERED THAT THE TECHNOLOGIST HAD SOMETHING ON THEIR FINGER AT THE TIME OF THE REPORTED ISSUE. THE FSE TESTED THE SYSTEM'S TOUCHSCREEN WITH AND WITHOUT LOTION TO TRY AND REPRODUCE THE EVENT. THE EVENT WAS REPRODUCED WITH LOTION ON THE FINGER. THE REVIEW OF LOG FILES WERE INCONCLUSIVE. THE CUSTOMER WAS INFORMED TO USE DRY HANDS AND /OR CLEAN THE TOUCHSCREEN ON A REGULAR BASIS TO AVOID PARTICLES ON THE SCREEN. THE SYSTEM IS EQUIPPED WITH SAFETY HARDWARE AND SOFTWARE LIMITS. IF THE COLLIMATOR COMES IN CONTACT WITH A PATIENT OR OBJECT, THE SYSTEM WILL ACTIVATE A SYSTEM EMERGENCY STOP AND HALT MOTION TO THE SYSTEM IN A CONTROLLED FASHION, PREVENTING SERIOUS INJURY TO A PATIENT, OPERATOR OR BYSTANDER. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT THE SITE WAS PERFORMING A SCAN WHEN THE TECHNOLOGIST USING THE HANDCONTROLLER ON THE TOUCHSCREEN AND WHEN THE TECHNOLOGIST REMOVED THEIR FINGER FROM THE TOUCHSCREEN DETECTOR 1 CONTINUED TO MOVE IN TOWARDS THE PATIENT. THE PATIENT TRIED TO INHALE THEIR ABDOMEN TO AVOID THE DETECTOR ARM FROM CONTACTING THEM. HOWEVER, THE DETECTOR CONTINUED TO MOVE IN AND EVENTUALLY CONTACTED THE PATIENT'S ABDOMEN. THE COLLISION SENSORS ON THE DETECTOR WERE TRIGGERED, ACTIVATING AN EMERGENCY STOP AND HALTED ALL SYSTEM MOTION. THERE IS NO REPORT OF PATIENT INJURY AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217065 PRECEDENCE 6 SLICE KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 2169-3002A

    Patients

    Seq Age Sex Outcome Treatment
    1