BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACT COUCH

    MDR report key: 777090 · Received November 3, 2006

    Report

    Report Number
    2914292-2006-00040
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 23, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 AND SAFETY MANUAL, PROVIDE INSTRUCTION AND HAZARD WARNINGS (WITH RESPECT TO HAND PLACEMENT), WHICH HELPS TO ENSURE THE SAFE OPERATION OF THE EQUIPMENT.

    Description of Event or Problem · 1

    FOUR (4) THERAPIST WERE SETTING UP A PT FOR TREATMENT. THEY RELEASED THE LONGITUDINAL LOCKS, AND MANUALLY MOVED THE PT INTO THE TREATMENT FIELD. ONE OF THE THERAPISTS WAS ON THE KLYSTRON SIDE OF THE TABLE AT THE FOOT OF THE PT. AS THE LONGITUDINAL CARRIAGE WAS MOVED INTO THE FIELD, THE THERAPIST'S LEFT RING FINGER WAS CAUGHT BETWEEN THE LATERAL CARRIAGE ASSEMBLY AND THE STRETCHER ASSEMBLY. THE THERAPIST NEEDED SURGERY ON HER FINGER AND WAS HOSPITALIZED DUE TO THIS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O