BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON HDR (CLASSIC)

    MDR report key: 224029 · Received May 12, 1999

    Report

    Report Number
    1121753-1999-00005
    Event Type
    Malfunction
    Date Received
    May 12, 1999
    Date of Event
    April 16, 1999
    Report Date
    May 12, 1999
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A HIGH DOSE RATE TREATMENT THE TREATMENT CONTROL UNIT (TCU) OF THE MHDR STOPPED UPDATING THE PRINTER AND THE LCD. THE LOCKUP OCCURRED WHILE THE SOURCE WAS TREATING IN THE 9TH CATHETER OF A 10 CATHETER PLAN. THE PHYSICIST WAS MONITORING THE TREATMENT WITH THE AID OF STOPWATCH. HE NOTED THE LCD WAS NOT UPDATING THE TREATMENT RECORD. THE PHYSICIST VERIFIED THAT THE 9TH CATHETER WAS TREATED BY TIMING WITH THE STOPWATCH. SOURCE WAS RETURNED TO SAFE AFTER NORMAL COMPLETION OF THE CHANNEL. TCU DID NOT INITIATE TREATMENT OF THE LAST CHANNEL. NO ERROR CODE WAS DISPLAYED. A NUCLETRON FIELD SERVICE ENGINEER WENT ON SITE ON THE MORNING OF MARCH 19 AND USING THE HAND HELD TERMINAL DETERMINED THAT TREATMENT OF THE LAST DWELL POSITION WAS COMPLETED IN IT ENTIRETY AS PROGRAMMED. THE PRESCRIBED DOSE WAS DELIVERED TO THE PROGRAMMED AND INTENDED POSITIONS IN CHANNEL 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON HDR (CLASSIC) REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM JAQ NUCLETRON BV M/HDR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other