BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

    MDR report key: 3060022 · Received April 16, 2013

    Report

    Report Number
    2910081-2013-02515
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K031764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED EVENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) BECAME AWARE THAT THE LIGHT FIELD FOR THE Y1 JAW SHOWED THAT IT WAS INCORRECTLY POSITIONED AT 0.5 CM INSTEAD OF BEING CORRECTLY POSITIONED AT 5.0 CM DURING AN INVESTIGATION DURING A SERVICE CALL. A LEFT-KEY RESET WAS PERFORMED HOWEVER IT DID NOT MOVE THE Y1 JAW FROM THE INCORRECT FIELD AND THERE WAS NO INTERLOCK THAT WOULD PREVENT A TREATMENT FROM OCCURRING. REPORTEDLY, THE Y1 AND Y2 JAWS WERE SET TO MOVE TO 10 CM HOWEVER THE Y2 JAW MOVED TO 10 CM BUT THE Y1 JAW ONLY MOVED TO 3.5 CM. AT THAT POINT, INTERLOCK 63 CONTROLLERS 0 SUB-FAULT 9 'Y1 POSITION SENSOR MISMATCH' OCCURRED. ANOTHER LEFT-KEY RESET WAS AGAIN PERFORMED BUT ALSO DID NOT GENERATE AN INTERLOCK THAT WOULD PREVENT A TREATMENT IN AN INCORRECT FIELD. THE SYSTEM WAS TURNED OFF AND THE Y1 JAW WAS MOVED. THE CONTROLLER 0 INTERLOCK TRIPPED AGAIN AND IT WAS SEEN IN THE SERVICE MENU, THAT Y1 POTENTIOMETER WAS AT -9.3 AND THE Y1 ENCODER WAS AT -9.0. AFTER YET ANOTHER LEFT-KEY-RESET WAS PERFORMED, THE ENCODER HAD THE POSITION (-9.3) OF THE POTENTIOMETER, AND AGAIN NO INTERLOCK WAS GENERATED THAT WOULD PREVENT AN INCORRECT FIELD TO BE TREATED. THERE IS NO REPORT THAT A MISTREATMENT OR PATIENT INJURY HAS OCCURRED. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163481 ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 5863472

    Patients

    Seq Age Sex Outcome Treatment
    1 ENCODER| G31 MOTOR CONTROL PCB| 4 CHANNEL V/F PCB| POTENTIOMETER