BEUDAMED
    FDA Adverse Event Other Summary report: N

    COHERENCE THERAPIST 2.1

    MDR report key: 2507535 · Received March 23, 2012

    Report

    Report Number
    2910081-2012-00023
    Event Type
    Other
    Date Received
    March 23, 2012
    Date of Event
    November 23, 2011
    Report Date
    February 23, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED OCCURRENCE ON 02/23/2012. SIEMENS INVESTIGATION REVEALS THAT IN THE REPORTED SCENARIO THE SYSTEM WORKS AS SPECIFIED. CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON FEBRUARY 23, 2012 THAT THE PRIMEVIEW SYSTEM DID NOT GIVE ANY WARNINGS REGARDING EXCEEDING FRACTIONS OR DOSE. REPORTEDLY, THE CUSTOMER INADVERTENTLY SET UP 2 DOSE TRACKING SITES FOR THE SAME FIELD. HOWEVER, ON THE SECOND DAY OF TREATMENT THE DOSE AND FRACTIONS FOR ONE OF THE SITES WOULD HAVE BEEN EXCEEDED. PRIMEVIEW SYSTEM DID NOT GIVE ANY WARNINGS REGARDING EXCEEDING FRACTIONS OR DOSE SINCE IT ONLY TRACKS THE DOSE FOR THE SITE WHICH CONTAINS THE FIELD. THERE IS NO MISTREATMENT REPORTED FOR THIS OCCURRENCE. HOWEVER, THE COMPLAINT DESCRIBES AN OVERDOSE OF LESS THAN ONE (1) FRACTION. IN A CASE WHERE THE USER MAKES A MISTAKE WHEN SETTING UP THE DOSE TRACKING, IT MAY HAPPEN THAT PRIMEVIEW/LANTIS DOES NOT PREVENT FROM OVERDOSE OF ONE OR EVEN MORE FRACTIONS. AN OVERDOSE OF SEVERAL FRACTIONS MAY POTENTIALLY RESULT IN A SERIOUS INJURY. IN A CASE THAT DOSIMETRY PARAMETERS ARE NOT CORRECTLY SETUP, THERE WILL BE NO WARNING WHEN THE PRESCRIBED DOES HAS BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENCE THERAPIST 2.1 ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 08147667 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SERIAL NO. (B)(4)| LANTIS (AND PRIMEVIEW 2.2.09), MATERIAL NO. 058359