BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY TF PET/CT

    MDR report key: 3132744 · Received May 24, 2013

    Report

    Report Number
    1525965-2013-00138
    Date Received
    May 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K052640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUT 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

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER THAT THE OPERATOR WAS ATTEMPTING TO REMOVE A PT FROM THE IMAGING TABLE AFTER STOPPING AN ACQUISITION BEFORE IT WAS COMPLETED. THE TRAINED PROFESSIONAL WAS HOLDING THE TABLE UNLOAD BUTTON WHEN THE TABLE MOVED IN, AND NOT OUT, AS IT SHOULD HAVE. THE TABLE TRAVELLED ONLY A FEW MILLIMETERS WHEN THE TRAINED PROFESSIONAL RELEASED THE BUTTON AND REMOVED THE TABLE FROM THE GANTRY USING THE "TABLE OUT" AND TABLE DOWN" COMMANDS ON THE GANTRY CONTROL PANEL. THERE WAS NO HARM TO PT, OPERATOR OR BYSTANDER WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231551 INGENUITY TF PET/CT KPS, JAK KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882456

    Patients

    Seq Age Sex Outcome Treatment
    1