BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 2821971 · Received October 1, 2012

    Report

    Report Number
    2910081-2012-08301
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 30, 2012
    Report Date
    September 4, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS¿ CUSTOMER SERVICE ENGINEER INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON CONCLUSION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2012 THAT DURING AN AUTO SEQUENCE TREATMENT THE GANTRY FIELD THAT WAS SETUP AT 150 DEGREES DID NOT MOVE TO THE NEXT FIELD OF 190 DEGREES. THE GANTRY MOVED CLOCKWISE THROUGH 0 DEGREE. REPORTEDLY, THE GANTRY MOVED THROUGH THE 180 DEGREES IN THE CLOCKWISE DIRECTION UNTIL IT REACHED THE LIMIT SWITCH AND STOPPED AT APPROXIMATELY 207 DEGREES. THE GANTRY LIMIT SWITCH INTERLOCK APPEARED AT THAT POINT, THEN A SECOND INTERLOCK (CONTROLLER ), (ERROR 53) APPEARED. IT WAS REPORTED THAT DUPLICATION OF THE REPORTED SCENARIO WAS ACHIEVED BY SIEMENS¿ CUSTOMER SERVICE ENGINEER; HOWEVER, RELEASING THE MOTION ENABLE BUTTONS STOPPED THE GANTRY MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 05857912 NA

    Patients

    Seq Age Sex Outcome Treatment
    1