BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA

    MDR report key: 1624888 · Received February 19, 2010

    Report

    Report Number
    9611894-2010-00002
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 17, 2010
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K081281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERDOSED. A 40CGY WAS DELIVERED AND 400CGY PLANNED. ONCENTRA BRACHY DID NOT UPDATE THE DWELL TIMES AFTER THE USER SELECTED 5MM BOX AND CHANGED THE F-FACTOR. WHEN THE PROBLEM WAS DISCOVERED 40CGY X 2 WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA ONCENTRA BRACHY SOFTWARE MUJ NUCLETRON BV OTP 3.3 SP1

    Patients

    Seq Age Sex Outcome Treatment
    1