BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 678330 · Received February 10, 2006

    Report

    Report Number
    678330
    Event Type
    Injury
    Date Received
    February 10, 2006
    Date of Event
    January 30, 2006
    Report Date
    February 10, 2006
    Manufacturer
    DIRECTOR OF REGULATORY AFFAIRS - MEDICAL PRODUCTS
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    A STAFF MEMBER DUCKED UNDER RAILING OF C-ARM TO ASSIST WITH ROLLING PATIENT. HE OR SHE MOVED OUT OF CENTER OF C-ARM AFTER PATIENT TRANSFERRED USING SAME ACCESS POINT. THE PHYSICIAN BEGAN TO MOVE C-ARM PRIOR TO STAFF SAFELY EXITING. THE STAFF MEMBER WAS CAUGHT BETWEEN C-ARM AND STATIONARY PORTION OF C-ARM APPARATUS. THE STAFF MEMBER SUSTAINED CRUSH INJURY WITH BILATERAL CLAVICLE FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * X-RAY SYTEM, ANGIOGRAPHIC IZL DIRECTOR OF REGULATORY AFFAIRS - MEDICAL PRODUCTS CLINIX MP PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R