BEUDAMED
    FDA Adverse Event Summary report: N

    MX 16-SLICE

    MDR report key: 3016944 · Received March 15, 2013

    Report

    Report Number
    3004761566-2013-00001
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 17, 2013
    Manufacturer
    PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K091195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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

    AFTER A CT SCAN WAS PERFORMED ON A PATIENT, THE OPERATOR OF THE MX 16-SLICE SYSTEM PROCEEDED TO MOVE THE TABLE TOP BACKWARDS WHILE OPERATING THE CONTROL FROM THE GANTRY LEFT CONTROL PANEL. THE OPERATOR DID NOT NOTICE THAT A PHYSICIAN'S HAND WAS IN THE GUIDING RAIL GROOVE DURING THE TABLE TOP MOVEMENT. THE PHYSICIAN WAS NOT ABLE TO MOVE HIS HAND OUT OF THE WAY AND HE RECEIVED A FINGER INJURY (CUT IN THE SKIN AND A FRACTURED INDEX FINGER). THE PHYSICIAN RECEIVED FIRST AID TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110947 MX 16-SLICE JAK PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. 728131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other