BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR AVANT GARDE

    MDR report key: 884311 · Received September 6, 2006

    Report

    Report Number
    2910081-2006-00012
    Event Type
    Malfunction
    Date Received
    September 6, 2006
    Date of Event
    August 4, 2006
    Report Date
    August 4, 2006
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS & CONCLUSION: COULD NOT DUPLICATE ISSUE AND INVESTIGATION IS CONTINUOUS. CUSTOMER ATTEMPTED A SIMILAR SETUP ON THREE ADDITIONAL LINEAR ACCELERATOR MACHINES (SAME MACHINE TYPE) FROM THE SAME SITE. NO PT INVOLVEMENT REPORTED DURING THE SIMULATION.

    Description of Event or Problem · 1

    A PRODUCT ISSUE WAS REPORTED BY THE CUSTOMER WHEN THE FLAT PANEL POSITIONER (FPP) IMAGING DEVICE (FPP) WAS BEING EXTENDED USING THE MOTION ENABLE SWITCH FROM THE CONTROL CONSOLE DEVICE LOCATED OUTSIDE THE TREATMENT ROOM. THE FPP STOPPED MOVEMENT, BUT AN UNINTENDED MOVEMENT OF THE TREATMENT TABLE WAS NOTICED BY ONE OF THE OPERATORS. THE OPERATOR WAS ALERTED BY THE TREATMENT TABLE'S "BEEPING" SOUND AS IT MOVED VERTICALLY UPWARDS. THE OPERATOR IMMEDIATELY RELEASED THE MOTION ENABLE SWITCH AND THE TREATMENT TABLE'S VERTICAL MOVEMENT STOPPED. IT IS IMPORTANT TO NOTE THAT THE RELEASE OF MOTION ENABLE SWITCHES AND THE RED EMERGENCY STOP BUTTON STOPS ALL SYSTEM MOTION. PT INVOLVEMENT: PT WAS LYING ON THE TREATMENT TABLE WHEN THE INCIDENT OCCURRED; HOWEVER, NO REPORT OF INJURY OR EQUIPMENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR AVANT GARDE ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 5863472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1