BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYPE - S PATIENT POSITIONING SYSTEM

    MDR report key: 2083398 · Received May 6, 2011

    Report

    Report Number
    2083398
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 4, 2011
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TO RECEIVE OR HAD RECEIVED RADIATION TREATMENT. PATIENT WAS LYING ON THE TABLE - REACHED UP AND GRABBED TOP OF TABLE, (HEAD EXTENSION) DISLODGING IT, AND PATIENT FELL TO THE FLOOR.THE HEAD EXTENSION SUPPORTS THE PATIENT'S HEAD DURING TREATMENT. THIS DEVICE DID NOT HAVE A LOCKING MECHANISM TO HOLD IN PLACE. CIVCO COLLABORATED WITH SIEMENS MEDICAL SOLUTIONS - THE HEAD EXTENSION PRODUCT WAS MODIFIED TO INCLUDE A LOCKING LATCH WHICH WAS DESIGNED TO HELP SECURE THE DEVICE TO THE TABLE TOP/COUCH TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYPE - S PATIENT POSITIONING SYSTEM RADIATION THERAPY, PATIENT POSITIONING SYSTEM, HEAD EXTENSIO IYE CIVCO MEDICAL INSTRUMENTS CO., INC. MTCFHNCV *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NO OTHER THERAPIES