BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI PRO ACCEPT

    MDR report key: 3303893 · Received July 29, 2013

    Report

    Report Number
    9614952-2013-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    July 22, 2013
    Manufacturer
    IBA DOSIMETRY GMBH
    Product Code
    IYE
    PMA / PMN Number
    K011763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST EVAL OF THE COMPLAINT LEAD TO AN ACCEPTABLE RISK LEVEL WHERE NO ADDITIONAL MEASURES WERE NEEDED BUT IBA DECIDED TO FURTHER INVESTIGATE WITH EXPERT REVIEW FROM R AND D DEPARTMENT. SECOND EVAL WITH R AND D WAS LEADING TO A NEW RISK CLASSIFICATION DIFFERENT FROM THE INITIAL ASSUMPTION AS DONE WHEN RECEIVING THE COMPLAINT. NEW EVAL OF THE COMPLAINT SHOWED THAT REPORTED PROBLEM COULD LEAD TO A SERIOUS INJURY IF IT WOULD NOT BE IDENTIFIED, ESPECIALLY WHEN A TREATMENT PLANNING SYSTEM (TPS) WITH DYNAMIC WEDGES IS COMMISSIONED. THE TREATMENT PANNING SYSTEM WOULD CALCULATE WRONG DOSE DUE TO POSSIBLE MIRRORED DATA, MEASURED WITH OMNIPRO ACCEPT 7.4A. THERE IS A REMOTE PROBABILITY THAT THE PHYSICIST WOULD NOT RECOGNIZE THE COMMISSIONING FAILURE. INTERNAL DETAILED ROOT CAUSE ANALYSIS WAS FINALIZED IN (B)(4) 2013. ROOT CAUSE OF THE PROBLEM IS A FAILURE IN THE SOFTWARE. THE RESAMPLING METHOD, EXECUTED FOR THE SCALED DATA MEASURED WITHOUT REFERENCE, COULD DETERMINE AND USE THE WRONG ORIENTATION TO COPY THE INTERPOLATED VALUES TO THE RESULT BUFFER. THIS IS DEPENDING ON THE WATER PHANTOM ORIENTATION AND THE SCANNING DIRECTION. REPORTED MALFUNCTION OF THE MEDICAL DEVICE IS A REPRODUCIBLE FAILURE IN THE SOFTWARE. NEW SOFTWARE RELEASE IS PLANNED FOR (B)(4) 2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN HE USED THE RESAMPLING FUNCTION OF OMNIPRO ACCEPT 7.4A FOR THE SCANS WITHOUT REFERENCE CHAMBER THE RESAMPLED X- AND Y- CURVES ARE MIRRORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354773 OMNI PRO ACCEPT GENERAL DOSIMETRY SYSTEM IYE IBA DOSIMETRY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1