BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 1791930 · Received August 3, 2010

    Report

    Report Number
    2910081-2010-00031
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL) THIS ISSUE HAS BEEN DETECTED WHILE PERFORMING UI (B)(4). WORST CASE: IF THE BELT BREAKS WHILE THE GANTRY POSITION IS IN THE RANGE OF 100 TO 260 DEGREES (WORST CASE: 180 DEGREES), THE PATIENT MAY BE HURT BY THE MVPP RUNNING UNCONTROLLED DOWN AND MAY HIT THE PATIENT AND MAY CAUSE A SERIOUS INJURY. PROBABILITY: B (IMPROBABLE) THE MISSING PLATE WILL BE DETECTED WHILE PERFORMING THE UI. THE UI IS NEARLY COMPLETED (92%) AND THIS IS THE FIRST TIME THAT WE HEARD ABOUT A MISSING PLATE. NO OTHER PRODUCTS ARE AFFECTED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ARTISTE LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. DURING PERFORMING AN UPDATE (B)(4), IT WAS DISCOVERED THAT THE CAM DISC (B)(4) (CALLED ALSO AS ARRESTING PLATE) WAS NOT INSTALLED. THERE WAS NO MISTREATMENT OR INJURY REPORTED. PRELIMINARY ASSESSMENT IS DESCRIBED. CORRECTIVE ACTION DECISION IS PENDING FINAL INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BRAND NAME: ARTISTE MV ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1