BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 5966204 · Received September 21, 2016

    Report

    Report Number
    2240869-2016-52796
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 26, 2016
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE REPORTED EVENT IS ON-GOING. EMERGENCY STOP BUTTONS ARE AVAILABLE ON THE UNIT TO STOP ALL SYSTEM MOVEMENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WAS SUBMITTED SEPTEMBER 21, 2016.

    Description of Event or Problem · 1

    THE CUSTOMER HAD A PAUSE ENTERED BETWEEN THE SECOND SUPERIOR ANTERIOR OBLIQUE (SAO) FIELD AND THE POSTERIOR-ANTERIOR (PA) FIELD TO PREVENT AUTOMATIC GANTRY ROTATION IN ORDER TO AVOID ANY COLLISION WITH PATIENT AND TABLE. THE PATIENT WAS DUE FOR A FILM OF THE PA FIELD. DUE TO RISK OF COLLISION THE THERAPISTS PRESENT AT THE TREATMENT DISABLED THE AUTO DEPLOY ON THE FLAT PANEL. WHEN THE THERAPISTS DOWNLOADED THE TWO FIELDS THERE WAS A STOP/PAUSE ON THE PA FIELD AS USUAL. WHEN THE TREATMENT OF THE SECOND SAO FIELD WAS COMPLETED, THE THERAPISTS NOTICED THAT THE GANTRY STARTED ROTATING ON ITS OWN, EVEN WITH A PAUSE STILL BEING DISPLAYED. THE THERAPISTS HIT THE RAD OFF BUTTON AND THE BUTTON TO OPEN THE DOOR BEFORE THE GANTRY HIT THE PATIENT'S ARMS, THE VAC-LOC AND THE TABLE. THE GANTRY MOVEMENT WAS STOPPED. IT IS ASSUMED THAT HAVING A FILM IN THE SESSION DISABLED THE PAUSE THAT HAD BEEN ENTERED EARLIER, HOWEVER, THE PAUSE WAS STILL DISPLAYED DUE THE AUTO-DEPLOY BEING DISABLED. THERE ARE NO INJURIES ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619783 ONCOR IMPRESSION PLUS MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM IYE SIEMENS HEALTHCARE GMBH 5857912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other