BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY CT

    MDR report key: 3132767 · Received May 24, 2013

    Report

    Report Number
    1525965-2013-00137
    Date Received
    May 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    PHILIPS RECEIVED INFORMATION FROM THE FIELD SERVICE ENGINEER (FSE) WHO WAS PERFORMING SERVICE ON THE PHILIPS CT SYSTEM WITH THE FRONT GULL-WING COVER OPEN TO ACCESS THE ROTATING FRAME. THE SYSTEM IS DESIGNED TO BE ABLE TO OVERRIDE THE GANTRY FRONT COVER GULL-WING SWITCH BY "PULLING IT OUT". THE FSE PULLED THE SWITCH OUT TO ENERGIZE THE GANTRY. THE GULL-WING SAFETY "FRIDGE" SWITCH SLIPPED OUT OF THE METAL ENCLOSURE AND THE SWITCH CONTACT SHORTED TO THE CHASSIS (THERE IS 120VAC ON SWITCH CONTACTS). THIS SHORT CAUSED AN OPEN FOIL RUN ON THE AC CONTROL UNIT. THE FSE CONFIRMED HE WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231599 INGENUITY CT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1