BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERATRON

    MDR report key: 3848672 · Received May 13, 2014

    Report

    Report Number
    3006946288-2014-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 14, 2014
    Manufacturer
    BEST THERATRONICS LTD.
    Product Code
    IWB
    PMA / PMN Number
    863180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CUSTOMER'S DESCRIPTION AND DETAILS FROM BEST THERATRONIC'S LAST VISIT ((B)(6) 2012 SOURCE CHANGE), THE PROBLEM SEEMS TO BE NORMAL WEAR AND TEAR OF THE AIR SYSTEM AND SWITCHES. THIS UNIT HAS BEEN IN USE FOR 21 YRS AND IS BEYOND THE USEFUL LIFE OF 18 YRS FOR THIS DEVICE. BEST THERATRONICS RECOMMENDS A PMI EVERY 5 YRS AS PER THE OPERATOR MANUAL HOWEVER, THE CUSTOMER HAS NOT REQUESTED ANY SERVICE BY BEST THERATRONICS.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE RADIOACTIVE SOURCE FAILED TO FULLY RETURN TO SHIELDED POSITION AT THE END OF THE PT TREATMENT. THE SOURCE WAS ONLY ONE INCH AWAY FROM BEING FULLY SHIELDED. THE PT WAS REMOVED AND THE TREATMENT ROOM WAS DEEMED TO BE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285911 THERATRON COBALT THERAPY IWB BEST THERATRONICS LTD. PHOENIX

    Patients

    Seq Age Sex Outcome Treatment
    1