BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESKTOP PRO R7.0.1

    MDR report key: 3608500 · Received February 5, 2014

    Report

    Report Number
    9617016-2014-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 7, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K080585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INHIBITED SAFELY WHEN A FAULT OCCURRED: THE PRF BLANKING PULSE (SIGNAL) WAS PRESENT FOR A LONGER PERIOD THAN NORMAL. A SECOND FAULT RESULTED IN THE REAL-TIME CONTROL SYSTEM REPORTING THE WRONG DOSE DELIVERED WHICH WAS THEN PASSED ONTO MOSAIQ. THE LCD DISPLAYED THE CORRECT DOSE. THE CLINICAL INSTRUCTIONS FOR USE STATES THAT THE USER SHOULD TREAT THE LCD DOSE AS THE MASTER WHENEVER A FAULT OCCURS. THE ROOT CAUSE OF THE SECOND FAULT IS BEING INVESTIGATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION TO THAT PREVIOUSLY SUPPLIED REGARDING THE SECOND FAULT. THE MANUFACTURER HAS COMPLETED ITS INVESTIGATION. IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE FAULT OF THE SECOND ISSUE. A FIX FOR THIS ISSUE WILL BE CONSIDERED BY THE MANUFACTURER IN A FUTURE RELEASE. THE CUSTOMER HAS BEEN REMINDED THAT THE LCD SHOULD ALWAYS BE CHECKED WHEN AN ABNORMAL TERMINATION OCCURS. THE SYSTEM INHIBITED SAFELY WHEN A FAULT OCCURRED. THIS IS THE MANUFACTURER'S FINAL REPORT.

    Description of Event or Problem · 1

    INCORRECT DOSE REGISTRATION , 435MU. AFTER 80MU LINAC TERMINATES ON AN ERROR. TREATMENT WAS RE-RUN IN QA MODE WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73945 DESKTOP PRO R7.0.1 ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1