BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 2823578 · Received November 2, 2012

    Report

    Report Number
    1525965-2012-00088
    Date Received
    November 2, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 25, 2012
    Manufacturer
    PHILIPS MEDICLA SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    (B)(4). PHILIPS RECEIVED A CUSTOMER COMPLAINT THAT STATED DURING DAILY CT QUALITY CONTROL, THE TECHNOLOGIST NOTICED THAT THE MATTRESS PAD PROTECTOR WAS ABOUT TO GET CAUGHT UNDERNEATH THE IMAGING TABLE AND PLACED THEIR FINGERS IN THE PATCH OF THE MOVING IMAGING TABLE TO PREVENT IT FROM GETTING CAUGHT. AS THE TECHNOLOGIST TRIED TO PULL THE MATTRESS PAD PROTECTOR OUT FROM UNDERNEATH THE IMAGING TABLE, THEIR FINGER CAUGHT UNDER THE MOVING IMAGING TABLE AND ONE OF THE ROLLERS LOCATED ON THE IMAGING COUCH. THE TECHNOLOGIST WAS NOT ABLE TO ACTIVATE ONE OF THE EMERGENCY STOP BUTTONS ON THE SYSTEM TO STOP THE SYSTEM DUE TO THEIR POSITION BY THE IMAGING COUCH SO THE TECHNOLOGIST DECIDED TO FREE HER FINGERS FROM BETWEEN THE ROLLERS AND IMAGING PALLET. IN THE PROCESS OF FREEING THEIR FINGERS, THE TECHNOLOGIST BROKE THE TIP OF THEIR FINGER. THE TECHNOLOGIST WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION AND IT WAS DETERMINE THAT THEIR FINGERTIP WAS BROKEN AS A RESULT OF THE REPORTED EVENT AT THE SITE. ON THE DAY THAT THE FSE WAS INFORMED ABOUT THIS REPORTED EVENT, THE FSE CHECKED THE SYSTEMS SAFETY MITIGATION (I.E. EMERGENCY STOP BUTTONS AND COLLISION SENSORS) AND FOUND THEM OPERATING PROPERLY ON THE BRIGHT VIEW XCT CAMERA. THE FSE WENT ON TO TEST THE IMAGING TABLE MOTIONS AND FOUND THEM WORKING PROPERLY ON THE SYSTEM, TOO. THE FSE INSTRUCTED THE SITE TO REMOVE THE MATTRESS PAD WHEN THEY PERFORM THE CT (QC) ON THE BRIGHTVIEW XCT CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICLA SYSTEMS (CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention