BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEDENCE SPECT/CT

    MDR report key: 2426067 · Received January 19, 2012

    Report

    Report Number
    MW5023901
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 11, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NUCLEAR MEDICINE TECHNOLOGIST WAS USING THE TOUCH SCREEN CONTROL TO MOVE THE GAMMA CAMERA DETECTOR INTO POSITION AROUND A PT'S HEAD. SHE WAS OPERATING THE DETECTOR IN "FAST" MODE WHICH MOVES THE DETECTOR AT A RELATIVELY HIGH SPEED IN ORDER TO GET THE CAMERA WITHIN A FEW INCHES OF THE HEAD. ONCE IT GETS CLOSE TO THE PT, THE TECHNOLOGIST WILL RELEASE THE "FAST" MODE BUTTON AND THEN SWITCH TO NORMAL MODE. WHEN THE TECHNOLOGIST LET GO OF THE "FAST" MODE BUTTON THE GAMMA CAMERA CONTINUED TO MOVE IN FAST MODE AND DID NOT STOP, EVEN THOUGH THE TECHNOLOGIST WAS NO LONGER PRESSING ANY OF THE CONTROL BUTTONS. THE CAMERA WAS APPROX 8 INCHES AWAY FROM THE PT AND CONTINUED TO MOVE FOR ANOTHER 3-4 INCHES UNTIL THE TECHNOLOGIST MANAGED TO TRIGGERED A PRESSURE SENSITIVE PANEL ON THE CAMERA WHICH STOPPED THE MOTION. THE DETECTOR DID NOT COME IN CONTACT WITH THE PT. HAD THE TECHNOLOGIST NOT MANAGED TO STOP THE CAMERA, IT WOULD HAVE CONTACTED THE PT'S HEAD AND ACTIVATED THE PRESSURE SENSITIVE PANEL, LIKELY CAUSING MINOR INJURY TO THE PT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECEDENCE SPECT/CT NONE KPS PHILIPS HEALTHCARE PRECEDENCE SPECT/CT

    Patients

    Seq Age Sex Outcome Treatment
    1