BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX

    MDR report key: 46056 · Received October 15, 1996

    Report

    Report Number
    1121753-1996-09001
    Event Type
    Malfunction
    Date Received
    October 15, 1996
    Date of Event
    August 20, 1996
    Report Date
    October 14, 1996
    Manufacturer
    NUCLETRON CORP
    Product Code
    IWB
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS GIVEN TREATMENT FOR FIELDS 1 AND 2, AFTER THE SECOND FIELD TREATMENT THE FIRST FIELD WAS SHOWN AS OPEN FOR TREATMENT AND WOULD ALLOW ADD'L TREATMENT. ON AUGUST 20, 1996, A PT FILE WAS CREATED AT THE CO STATION (NEXT TO THE LINEAR ACCELERATOR) WITH FIELD 1. THIS FIELD WAS THEN TREATED. A SECOND FIELD (FIELD 2) WAS CREATED AND TREATED. THE SECOND FIELD WAS CREATED WITHOUT THE USE OF CONTROL C (COPY FIELD FUNCTION). IT WAS THEN NOTICED THAT THE FIRST FIELD INDICATED IT WAS AVAILABLE FOR TREATMENT WITHOUT THE FIELD BEING CALLED UP FOR TREATMENT AGAIN. THE PT FILE SHOWS FIELD 1 DID ACCUMULATE ITS DAILY DOSE BUT THIS FIELD DOES NOT SHOW ON THE TREATMENT HISTORY. THE LOG LIST SHOWS THAT BOTH FIELDS HAD BEEN TREATED NORMALLY. THERE WERE NO EDIT DOSES PERFORMED ON THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX RECORD AND VERIFY IWB NUCLETRON CORP 2.03C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other