BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 1942177 · Received December 13, 2010

    Report

    Report Number
    1942177
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 13, 2010
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM WAS WIDESPREAD DURING THE DAY. ABOUT 20 COMPUTERS RUNNING MOSAIQ SOFTWARE BEGAN TO LOCK-UP, ONE-BY-ONE. THE EX MOSAIQ COMPUTER LOCKED, BUT THE IX AND TX WAS WORKING. ELEKTA WAS MADE AWARE AND WAS AWAITING WORD FROM THE HOSPITAL TO SHUT-DOWN AND REBOOT THE SERVER. FINALLY, WHEN THE TX MOSAIQ COMPUTER LOCKED, WE FINISHED THE REMAINING PATIENT ON THE IX, AND THEN WE ORDERED ELEKTA TO REMOTELY RUN DIAGNOSTICS, THEN SHUT-DOWN THE SERVER, AND THEN REBOOT. WE WERE ASSISTED BY THE IS DEPARTMENT. THE PROCESS TOOK ABOUT AN HOUR. EVERYTHING CAME BACK NORMAL. THE SERVER FOR MOSAIQ WAS NOT ABLE TO BE REBOOTED BY OUR NETWORK APPS. WE HAD TO ALLOW IMPAC SUPPORT TO WEB INTO THE SERVER TO GET IT RUNNING AGAIN.THIS CAUSED A 2 HOUR DELAY TO THREE VARIAN LINAC RADIATION TREATMENT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIQ SOFTWARE, ONCOLOGY INFORMATION SYSTEM, IMAGE ENABLED LLZ IMPAC MEDICAL SYSTEMS, INC. MOSIAQ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *