BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACT COUCH

    MDR report key: 930043 · Received October 19, 2007

    Report

    Report Number
    2914292-2007-00039
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    October 8, 2007
    Report Date
    October 8, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS RECOGNIZED AS USE 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), WHICH HELP TO ENSURE THE SAFE OPERATION OF THE EQUIPMENT. HOWEVER, CAPA HAS BEEN OPENED TO INVESTIGATE POSSIBLE PRODUCT IMPROVEMENT TO FURTHER MITIGATE THIS DOCUMENTED RISK.

    Description of Event or Problem · 1

    OPERATOR A WAS HOLDING THE COUCH AT THE BACK OF COUCH TOP- FINGERS IN-BETWEEN THE TABLETOP EDGE AND MOVABLE CARBON FIBER RAIL. OPERATOR B WAS ASSISTING IN MOVING THE COUCH TOP WITH PT LOADED IN THE LONGITUDINAL DIRECTION. WITH OPERATOR A'S FIRST FINGERS IN THE LOCATION STATED ABOVE, A PINCH POINT EXISTED BETWEEN THE MOVING CARRIAGE AND THE STATIONARY LATERAL BASE. THE COUCH TOP WAS MOVED IN TOWARDS THE STAND TOO FAST AND BROKE THE BONE ON THE FINGER OF THERAPIST A.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR