BEUDAMED
    FDA Adverse Event Summary report: N

    MX 16-SLICE

    MDR report key: 2805898 · Received October 19, 2012

    Report

    Report Number
    3004761566-2012-00001
    Date Received
    October 19, 2012
    Report Date
    September 26, 2012
    Manufacturer
    PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K091195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    WHEN THE CUSTOMER MOVED THE PATIENT INTO THE GANTRY ON THE MX 16-SLICE, THE WEIGHT OF THE PATIENT LOADED MORE TO THE FRONT END OF THE SUPPORT ROLLERS. THE FOUR SCREWS MOUNTED TO THE REAR MOUNTING PLATE BECAME LOOSE AND THE TABLE TOP DETACHED. THE PATIENT WAS ON THE TABLE TOP AT THE TIME OF THE EVENT; HOWEVER, THE PATIENT WAS NOT INJURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1