BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE SI

    MDR report key: 2512270 · Received March 28, 2012

    Report

    Report Number
    2126677-2012-00030
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    PMA / PMN Number
    K943805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A: UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED AN INJURY WHILE PREPARING TO BE SCANNED ON A PRESTIGE SI X-RAY TABLE. AS THE PT WAS BEING ASSISTED ONTO THE TABLE HIS LEG CONTACTED A DAMAGED TABLE TOP HAND PROTECTION GUARD, AND AS A RESULT RECEIVED A CUT TO HIS LEG REQUIRING 2 STITCHES. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE SI FLUOROSCOPIC X-RAY SYSTEM JAA GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other