BEUDAMED
    FDA Adverse Event Summary report: N

    MOSAIQ

    MDR report key: 4135196 · Received September 26, 2014

    Report

    Report Number
    2950347-2014-00027
    Date Received
    September 26, 2014
    Report Date
    September 17, 2015
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE USER DID NOT HAVE THE WEDGE ORIENTATION SET UP CORRECTLY. THE WEDGE ORIENTATION FOR EDW25IN SHOULD BE BOTTOM INSTEAD OF TOP. WHEN WEDGE ORIENTATION FOR EDW25IN IS SET TO TOP, (B)(4) SENDS THE FIELD WITH EDW25IN WITH WEDGE ORIENTATION=TOP (OR 0) AS DEFINED TO 4D MACHINE; YET 4D SEES IT AS EDW25OUT BECAUSE 4D IS SET TO SEE THE WEDGE ORIENTATION=TOP (OR 0) AS EDW25OUT. AFTER TREATMENT, 4D SENDS EDW25OUT BACK TO (B)(4) WITH WEDGE ORIENTATION=TOP (OR 0) AND NO WEDGE ID. (B)(4) RECORDS THE WEDGE AS EDW25OUT, WHICH IS DIFFERENT FROM WHAT (B)(4) SENDS; HOWEVER, (B)(4) DOES NOT NOTE IT WITH A YELLOW STAR IN HISTORIC TREATMENT FORM. THIS ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT AND WILL BE FIXED IN A LATER VERSION. THERE WAS INSUFFICIENT INFORMATION TO DETERMINE WHETHER ANY PATIENTS WERE MISTREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCORRECT SET UP CONFIGURATION IN MOSAIQ HAS RESULTED IN A WEDGE ORIENTATION ERROR. INVESTIGATION IS IN PROGRESS TO CONFIRM CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602795 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1