BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMATRX OFFICE THERMO THERAPY SYSTEM

    MDR report key: 1853469 · Received September 28, 2010

    Report

    Report Number
    2183959-2010-00353
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 27, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS RECEIVED AND EVALUATED ON (B)(4) 2010. IT WAS DECONTAMINATED AND ITS EXTERIOR WAS VISUALLY INSPECTED. A NON-RELATED RETURNED GOODS PT CABLE, S/N (B)(4), WAS USED DURING THE FUNCTIONAL TESTING OF THE CONSOLE. THE CONSOLE WAS TESTED 5 TIMES OVER THE TWO-DAY PERIOD (B)(4) 2010 AND (B)(4) 2010. IN ALL FIVE CASES IT PERFORMED IN A ROUTINE MANNER WITH NO ISSUES OR READINGS OUTSIDE OF ESTABLISHED PARAMETERS. SYS SELF-CHECK, CALIBRATION AND OPERATION WERE NORMAL. THE STORED PT FILES WERE DOWNLOADED AND PRINTED OUT FOR INSPECTION. AMS IS STILL IN THE PROCESS OF REVIEWING MORE DATA AND FURTHER TESTS. AS SOON AS AMS IS AWARE OF ADDITIONAL INFO AND ABLE TO DRAW A CONCLUSION WE WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT# 2183959-2010-00354. ON (B)(6) 2010 PT HAD A THERMATRX THERMAL TREATMENT. DOCTOR CLAIMED INCONSISTENT READINGS ON THE TMX3000 UNIT AND NOW CLAIMS THE PT IS INCONTINENT. THERMATRX SHOW A MAX TEMP SENSOR READING OF 66 DEGREES HOWEVER THE GRAFT SHOWS 44 MAX. SECOND EXAMPLE IS THIS UNIT SHOWS A TREATMENT TIME OF 80 MINS WITH ONLY A 40 MIN TREATMENT TIME. THE GRAPH WATTAGE READING IS OFF THE CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMATRX OFFICE THERMO THERAPY SYSTEM TRANSURETHRAL MICROWAVE THERMOTHERAPY SYSTEM MEQ AMERICAN MEDICAL SYSTEMS, INC. TMX-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability