BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMVIEW THERAPY SIMULATOR

    MDR report key: 1300385 · Received January 28, 2009

    Report

    Report Number
    2910081-2009-00002
    Event Type
    Injury
    Date Received
    January 28, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 27, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPQ
    PMA / PMN Number
    K946053
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT INDICATES A SEVERITY: 3 (CRITICAL) PERSONAL INJURY OF HEAD, EVEN IF WEIGHT OF RELATED PART FALLING DOWN IS LOW. WORST CASE: EYES COULD BE INJURED. PROBABILITY: B (IMPROBABLE) MAINTENANCE INSTRUCTIONS DESCRIBE THAT THE CASSETTE HOLDER AND ITS PROPER FIXATION HAS TO BE CHECKED ON A MONTHLY BASIS.

    Description of Event or Problem · 1

    A PRODUCT ISSUE HAS BEEN REPORTED WITH OUR SIMVIEW THERAPY SIMULATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. A SCREW FELL OFF NEAR IMAGE INTENSIFIER AND HIT A PATIENT IN THE HEAD REQUIRING TREATMENT OF A MINOR INJURY CUT ABOVE THE EYE. SHOULD THIS FAILURE RE-OCCUR SERIOUS INJURY IS POSSIBLE. THERE WAS AN INJURY REPORTED. INITIAL RISK ANALYSIS IS COMPLETE. INITIAL CORRECTIVE ACTION DECISION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMVIEW THERAPY SIMULATOR SYSTEM, SIMULATION, RADIATION THERAPY KPQ SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1