BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUNO DRF

    MDR report key: 5104405 · Received September 23, 2015

    Report

    Report Number
    8021091-2015-00001
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Product Code
    KXJ
    PMA / PMN Number
    K050190
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WOULD APPEAR THE SAFETY SCREWS WERE DISCARDED AT INSTALLATION. THE PURPOSE OF THESE SCREWS IS TO PREVENT THE FOOTBOARD TO COMPLETELY DETACH FROM THE TABLE IN ORDER TO AVOID THE PATIENT TO FALL.

    Description of Event or Problem · 1

    PHILIPS WAS INFORMED BY A CUSTOMER THAT THE FOODBOARD OF THE DEVICE DETACHED FROM THE TABLE TOP WHILE A PATIENT WAS POSITIONED ON THE TABLE. AS A RESULT THE PATIENT FELL FORM THE TABLE AND PATIENT HEAD AND BACK WERE INJURED. THE PATIENT WAS MOVED TO ER FOR EXAMINATION AND A MUSCLE RELAXANT WAS PRESCRIBED. THE PATIENT ASKED FOR A FOLLOW-UP VISIT AFTER A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629407 JUNO DRF TABLE, RADIOLOGIC KXJ VILLA SISTEMI MEDICALI S.P.A. 709020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other