BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX

    MDR report key: 116930 · Received August 19, 1997

    Report

    Report Number
    1121753-1997-00026
    Event Type
    Malfunction
    Date Received
    August 19, 1997
    Date of Event
    October 23, 1996
    Report Date
    August 19, 1997
    Manufacturer
    NUCLETRON BV
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOR A SIEMENS KD IN USE, A REPORT THAT A WRONG KEYSTROKE INDUCED NO TREATMENT HISTORY. IF ESC KEY IS PRESSED ON VERIFLEX KEYBOARD, AFTER RAD-ON AND BEFORE RAD-OFF, VERIFLEX WILL FAIL TO RECORD THE TREATMENT AND WILL NOT REGISTER THE TREATMENT AS COMPLETE. IT IS THEN POSSIBLE TO RE-TREAT THE SAME FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX RECORD AND VERIFY SYSTEM IYE NUCLETRON BV VERSION 2.04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other