BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON HDR V2

    MDR report key: 1299164 · Received December 4, 2008

    Report

    Report Number
    9611894-2008-00016
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    February 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    PMA / PMN Number
    K953946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM INVESTIGATION INCLUDED A REVIEW OF THE FACILITY'S TREATMENT LOGS, THE TREATMENT CONTROL PANEL (TCP) FIRMWARE CODE, AND TREATMENT CONTROL STATION (TCS) SOFTWARE. IT COULD NOT BE DETERMINED WHAT CAUSED THE COMPUTER CRASH RESULTING IN A COMMUNICATION ERROR BETWEEN THE TREATMENT UNIT (TU) AND THE TREATMENT CONTROL PANEL (TCP) DURING TREATMENT. MOST LIKELY, THERE WAS A HARDWARE FAILURE IN THE PC WHICH CAUSED THE LOSS OF COMMUNICATION. IN THIS SITUATION, THE TCP PRINTOUT SHOULD PROVIDE A DETAILED TREATMENT RECORD. HOWEVER, AT THIS SITE THE TCP PRINTER PORT WAS NOT CONNECTED TO THE PRINTER. WHEN SERVICE REPLACED THE PC AND RECONNECTED THE TCP, THE PRINTOUT STILL COULD NOT BE MADE. INVESTIGATION OF THE SOFTWARE CODE SHOWS THAT THE TCP DATA IS ONLY RESET WHEN NEW TREATMENT DATA IS SENT FROM THE TCS OR WHEN A CHECK/SOURCE CABLE EXCHANGE AND CALIBRATION MODE IS SELECTED. MOST LIKELY THE TCP DATA WAS FLUSHED WHEN THE FACILITY TRIED TO REBOOT THE SYSTEM AND A PARTIAL RECOVERY WAS DONE. FULL RECOVERY WAS NOT APPARENTLY POSSIBLE BECAUSE OF THE PROBLEM WITH THE PC. THE TCP PRINTER CONNECTION SHOULD HAVE BEEN INSTALLED AND OPERATIONAL. INDEPENDENT SECONDARY TIMES KEPT BY USERS DURING TREATMENT PROVIDE A SAFEGUARD AT THE USER INTERFACE. NUCLETRON ISSUED A BULLETIN TO ALL CUSTOMERS THAT ADDRESSED THE IMPORTANCE OF THE EMERGENCY PRINTOUT AND ALTERNATIVE WAYS TO RETRIEVE TREATMENT DATA FROM THE AFTERLOADER IF THE PRINTER FAILS.

    Description of Event or Problem · 1

    CPU CRASHED IN TREATMENT. WHEN PC REBOOTED THERE WAS NO TREATMENT DATA FOR THE TREATMENT. CUSTOMER CALLED SUPPORT LINE. TECH SUPPORT TRIED TO HAVE CUSTOMER PRESS THE PRINT BUTTON ON THE TCP. CUSTOMER PRESSED PRINT, BUT NOTHING HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON HDR V2 HDR REMOTE AFTERLOADER JAQ NUCLETRON BV

    Patients

    Seq Age Sex Outcome Treatment
    1