BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO RT THERAPIST WORKSPACE V4.3.1

    MDR report key: 8560594 · Received April 29, 2019

    Report

    Report Number
    3002466018-2019-77454
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 10, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K132935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS COMPLETED A TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE IS THAT THERE ARE SOME SCENARIOS WHERE THE FPP MIGHT STRIKE/TOUCH THE PATIENT OR THE TREATMENT TABLE DURING THE AUTO-RETRACTION MOVEMENT, DEPENDING ON THE PATIENT POSITIONING AND/OR THE TABLE POSITIONING. THIS KIND OF SCENARIO APPLIES ONLY TO AUTOMATIC FPP MOVEMENTS DUE TO THE SPECIAL AUTO-RETRACTION PATH OF THE POSITIONER (WHICH IS A CURVED PATH BECAUSE ALL MOTORS ARE MOVING SIMULTANEOUSLY). IF A COLLISION OCCURS DURING THESE SCENARIOS, IT WOULD BE A SOFT TOUCH RATHER THAN A HARD IMPACT. A MODERATE PATIENT INJURY COULD RESULT, HOWEVER, IF EVEN A SOFT COLLISION OCCURRED. WHEN AUTOMATICALLY RETRACTING, THE FPP PERFORMS TWO MOVEMENTS SIMULTANEOUSLY. AS A CONSEQUENCE, THE FPP'S EDGE MAY LIFT UP A BIT DEPENDING ON THE INITIAL Z-POSITION. IF THERE IS TOO LITTLE CLEARANCE BETWEEN THE FPP'S EDGE AND THE TREATMENT TABLE, THE FPP'S EDGE COULD TOUCH THE TREATMENT TABLE. THE COLLISION DETECTION SYSTEM WOULD THEN ACTIVATE THE MOTION STOP INTERLOCK. IT IS RECOMMENDED THAT CLEARANCE CONSIDERATIONS BE MADE DURING TREATMENT PLANNING. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT THE CUSTOMER COMPLAINED THERE IS A RISK THAT THE TREATMENT TABLE AND FLAT PANEL POSITIONER (FPP) MAY COLLIDE WHEN THE FPP IS RETRACTED AUTOMATICALLY, ESPECIALLY IF THE SYNGO.RT THERAPIST FPP IS RETRACTED AUTOMATICALLY AFTER 2D IMAGING. THERE WAS NO REPORT OF PATIENT INJURY OR PATIENT MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353340 SYNGO RT THERAPIST WORKSPACE V4.3.1 ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH 8162815

    Patients

    Seq Age Sex Outcome Treatment
    1