BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 2071004 · Received April 18, 2011

    Report

    Report Number
    2910081-2011-00013
    Event Type
    Other
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). REASON: ACCORDING TO THE COMPLAINT DESCRIPTION A MODERATE INJURY OCCURRED DUE TO A USER ERROR. HOWEVER, THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY. THERE ARE EMERGENCY OFF BUTTONS INSTALLED AND THEY HAVE BEEN USED TO STOP THE GANTRY MOTION. THE USER PREVENTED FROM THE OCCURRENCE OF A SERIOUS INJURY. PROBABILITY: D (OCCASIONAL). REASON: THE SYSTEM ALLOWS CREATION OF A PAUSE FOR IMAGING ALTHOUGH NO IMAGING IS ACTIVE. THUS IT IS POSSIBLE, THAT THE USER MAKES A MISTAKE DURING CREATION OF THE USER DEFINED PAUSE, SO THAT A PAUSE IS DISPLAYED EVEN THOUGH NO PAUSE IS ACTIVE. ACCORDING TO THE USER MANUAL THE THERAPIST MUST SUPERVISE THE PT TREATMENT ALL THE TIME AND STOP ANY UNEXPECTED MOTION OF THE SYSTEM BEFORE A PT IS INJURED BY MOVING PARTS. FURTHER INVESTIGATION IS REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED WITH OUR ARTISTE MV LINEAR ACCELERATOR WITH IT ASSOCIATED RT THERAPIST PRODUCT SERIAL NUMBER 10004. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. DURING AN AUTO-SEQUENCE CONSISTING OF FOUR FIELDS, A STOP WAS INSERTED AFTER THE SECOND FIELD. AN IMAGING SEGMENT WAS INSERTED AS A PAUSE. THIS SEGMENT WAS DISPLAYED AS ACTIVE ALTHOUGH THERE WAS NO IMAGING OCCURRING DURING THE SEGMENT. AS A CONSEQUENCE, THE GANTRY DID NOT STOP DURING THE AUTO-SEQUENCE AND THERE WAS AN ACCIDENT WHERE THE PT'S LEG WAS SQUEEZED. THIS RESULTED IN A MINOR INJURY TO THE PT THAT DID NOT REQUIRE MEDICAL INTERVENTION. IT HAS BEEN DETERMINED THAT THE EVENT WAS CAUSED BY USER ERROR.

    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