BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO RT THERAPIST

    MDR report key: 2945106 · Received December 28, 2012

    Report

    Report Number
    2910081-2012-11170
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIOLOGY ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K103606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2012 THAT DURING AN IMRT THERE WAS AN MULTILEAF COLLIMATOR (MLC) INTERLOCK AT FIELD TWO (2). REPORTEDLY, THERE WERE 74.2 MU OF 74.4 MU TREATED BEFORE THE INTERLOCK OCCURRED. THE CUSTOMER RESET IN ORDER TO CONTINUE TREATMENT AND FIELD TWO (2) WAS THEN TREATED AGAIN WITH 18.5 MU. FIELD THREE WAS NOT TREATED AUTOMATICALLY; THEREFORE, THE CUSTOMER TREATED THAT FIELD MANUALLY. THERE IS NO REPORT OF INJURY TO THE PT. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNGO RT THERAPIST ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC., RADIOLOGY ONCOLOGY 08162815 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SW V4.2.108