BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS ONCOR

    MDR report key: 2162275 · Received July 8, 2011

    Report

    Report Number
    2910081-2011-00027
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INFORMED THE CUSTOMERS AND THE ACCESSORY MANUFACTURER THAT USE OF UNAUTHORIZED ACCESSORIES CAN RESULT IN RISK OF INJURY TO PATIENTS OR OPERATORS. RISK ASSESSMENT IDENTIFIED SEVERITIES OF CRITICAL AND MODERATE LEVELS FOR THE FOLLOWING REPORTED "POTENTIAL SERIOUS RISK" FINDINGS POST-INSTALLATION OF THE UNAUTHORIZED TABLETOP [PARTIAL LISTING] : DUE TO IMPROPER SETTINGS: THE VERTICAL LIMIT OF THE TABLE DOES NOT CORRESPOND TO THE ACCESSORY HEIGHT, CREATING A HIGHER RISK OF TABLE/GANTRY COLLISION OR LIMIT SWITCH DAMAGE DUE TO (MODIFIED) LOWER TABLE POSITION; AND OPERATOR USE OF "HOME" SETTING WILL IGNORE THE (MODIFIED) VERTICAL TABLE SETTINGS. THE ACCESSORY POWER SUPPLY WAS INTEGRATED TO THE SYSTEM EMERGENCY STOP CIRCUIT BUT NOT INCLUDED IN THE MOTION STOP SYSTEM CIRCUITRY. THE NARROWER DESIGN OF THE ACCESSORY EXPOSES THE TABLE'S LONGITUDINAL DRIVE BELT, REVEALING POTENTIAL PINCH POINTS AND POSSIBLE MECHANICAL CATCHES FOR HAIR, FINGERS, CLOTHING AND/OR SHEETS. THE LABELED PATIENT WEIGHT CAPACITY IS NO LONGER CORRECT. UNAUTHORIZED MODIFICATIONS CARRY POTENTIAL TO INVALIDATE LINAC MANUFACTURER'S NRTL TESTING/LABELING. PROBABILITY: C (REMOTE) THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. THE ACCESSORY TABLETOP HAS NOT BEEN VALIDATED BY SIEMENS. WE HAVE LEARNED OF TWO CUSTOMERS INSTALLING THIS ACCESSORY INDEPENDENTLY. THE ASSOCIATED SUBSYSTEM TXT 550 TABLE: (B)(4); DELIVERED (B)(6) 2007.

    Description of Event or Problem · 1

    UPON RE-REVIEW AND FURTHER ASSESSMENT OF INFORMATION PROVIDED THROUGH OUR SERVICE ORGANIZATION, SIEMENS HAS LEARNED OF SEVERAL POTENTIAL PRODUCT IMPACTS TO OUR ONCOR LINEAR ACCELERATOR AND ITS ASSOCIATED TXT TABLE. IN THE ABUNDANCE OF CAUTION, THIS ISSUE IS BEING REPORTED. SIEMENS CUSTOMER PURCHASED AND INSTALLED A MOTORIZED THIRD-PARTY ACCESSORY WHICH SIEMENS HAS NEITHER QUALIFIED NOR VALIDATED FOR USE WITH ITS LINEAR ACCELERATORS. THE ACCESSORY WAS IDENTIFIED AS THE PROTURA SIX DEGREE OF FREEDOM TABLETOP MANUFACTURED BY CIVCO. IT WAS REPORTED, THE INSTALLATION OF THIS UNAUTHORIZED ACCESSORY CREATED NUMEROUS POTENTIAL MECHANICAL, ELECTRICAL, AND SAFETY RISKS WHICH RESULTED FROM DESIGN INCOMPATIBILITIES BETWEEN THE ACCESSORY AND THE LINEAR ACCELERATOR SYSTEM AND TABLE. THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. SIEMENS HAS NOTIFIED BOTH THE CUSTOMER AND CIVCO REGARDING THESE INCOMPATIBILITIES AND DISCOURAGING USE/INSTALLATION OF ACCESSORY ON SIEMENS EQUIPMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1