BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACT COUCH

    MDR report key: 831268 · Received March 22, 2007

    Report

    Report Number
    2914292-2007-00007
    Event Type
    Injury
    Date Received
    March 22, 2007
    Date of Event
    February 21, 2007
    Report Date
    March 1, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN RECOGNIZED AS USER ERROR BY VARIAN MEDICAL SYSTEMS. LABELING PLACED ON THE COUCH, AS WELL AS IN THE USER MANUAL, PROVIDE INSTRUCTION AND HAZARD WARNINGS (WITH RESPECT TO HAND PLACEMENT), VARIAN IS LOOKING INTO A PREVENT ACTION TO PREVENT THIS PINCH-POINT ISSUE FROM HAPPENING IN THE FUTURE.

    Description of Event or Problem · 1

    RT-1 WAS IN THE LINAC VAULT TO SET UP THE LINAC BED FOR A PT. DURING THIS TIME, RT-2 WAS ASSISTING. AT SOME POINT, RT-1 HAD HER HAND NEAR THE MECHANICAL GEAR/ADJUSTMENT MECHANISM AND RT-2 BEGAN ADJUSTING THE BED UNKNOWING OF THE STATUS/POSITION OF RT-1. AS A RESULT, RT-1 HAD HER FINGER CAUGHT IN THE MECHANISM AND THE MECHANISM SEVERED HER FINGER FROM THE LAST KNUCKLE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACT COUCH PT POSITIONING TABLE JAI VARIAN MEDICAL SYSTEMS EXACT COUCH *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability