BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON

    MDR report key: 2476230 · Received February 21, 2012

    Report

    Report Number
    2476230
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 21, 2012
    Manufacturer
    NUCLETRON CORP
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED WITH ACCUBOOST APPLICATORS AND THE NUCLETRON HDR SYSTEM. AT THE END OF TREATMENT IT WAS NOTED THAT (A) THE ESTIMATED TREATMENT TIME ENDED PRIOR TO COMPLETION OF THE TREATMENT, AND (B) THE END OF TREATMENT REPORT INDICATED THAT NONE OF THE TREATMENT HAD BEEN GIVEN. HOWEVER, ALL OTHER INDICATIONS (TIME OF TREATMENT, RADIATION INDICATORS, CONSOLE PROGRESS INDICATORS) SHOWED THAT THE TREATMENT HAD BEEN GIVEN AS PRESCRIBED.MANUFACTURER'S SERVICE REPRESENTATIVE WAS ON-SITE THE FOLLOWING MORNING AND REVIEWED THE MACHINE LOGS. THESE INDICATED THAT THE TREATMENT WAS DELIVERED TO THE PATIENT AS PRESCRIBED. A COMMUNICATION FAILURE BETWEEN THE DELIVERY UNIT AND THE CONSOLE RESULTED IN THE INCORRECT REPORTING. AFTER INVESTIGATION, THE SERVICE REP REPORTED THAT THE MANUFACTURER WAS AWARE OF THE SOFTWARE ISSUE AND THAT A FIX WAS IN PROCESS FOR RELEASE LATER THIS YEAR. THE SOFTWARE ISSUE WAS SOLELY ONE OF REPORTING, NO ERROR IN TREATMENT IS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON BRACHYTHERAPY SYSTEM JAQ NUCLETRON CORP MICROSELECTRON C3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR