BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIONICS - TYCO

    MDR report key: 550191 · Received August 5, 2004

    Report

    Report Number
    MW1032976
    Event Type
    Malfunction
    Date Received
    August 5, 2004
    Date of Event
    July 15, 2004
    Report Date
    July 23, 2004
    Manufacturer
    RADIONICS - TYCO REPAIR VALLEYLAB
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LESIONING MODE UNIT TURNED OFF AFTER 10 SEC. THESE CAUSED CANCELLATION OF OR CASE. THIS IS SECOND TIME THIS OCCURRED. PREVIOUSLY 12/2003 SHIP OUT AND SENT BACK 1/2004. WITH COMPANY VERIFYING UNIT FUNCTIONING. NOT IN USE AGAIN UNTIL 7/2004. WHEN ABOVE OCCURRED ONCE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIONICS - TYCO RADIO FREQUENCY GENERATOR GXD RADIONICS - TYCO REPAIR VALLEYLAB RFG3C11760 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other