BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTONE LITHOTRIPTOR

    MDR report key: 6633543 · Received June 12, 2017

    Report

    Report Number
    3008262715-2017-00018
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    May 18, 2017
    Report Date
    August 1, 2017
    Manufacturer
    HEALTHTRONICS, INC.
    Product Code
    LNS
    PMA / PMN Number
    K010900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE REPORT NUMBER: (B)(4). FROM (B)(4) ON 5-18-2017 FIELD SERVICE ENGINEER (FSE) STATES: "SYSTEM HAS MULTIPLE ISSUE IN THE WATER SYSTEM. DURING TESTING WITH MONITOR SYSTEM STATUS, COMPONENTS WOULD NOT RESPOND TO ON/OFF COMMANDS. REPLACED THE WATER CONTROL PCB; CORROSION DAMAGE TO COMPONENTS CAUSING MULTIPLE FAULTS. SYSTEM TESTED IN ACCORDANCE WITH THE MANUFACTURER'S SERVICE MANUAL AND IS FULLY OPERATIONAL." FROM (B)(4) ON 7-14-2017 FSE STATES "WATER SYSTEM SERVICE DUE TO WATER INTRUSION/CORROSION. REPLACED TREAT VALVE, DI RECIRCULATION VALVE, WATER TREAT PUMP, WATER DRAIN PUMP, WATER TUBING, CLAMPS AND FITTINGS. REPLACED DISTILLED WATER AND VERIFIED NO LEAKS AND PROPER SYSTEM FUNCTION. SYSTEM TESTED IN ACCORDANCE WITH THE MANUFACTURER'S SERVICE MANUAL AND IS FULLY OPERATIONAL." DUE TO MULTIPLE PRODUCT COMPLAINTS RELATED TO WATER PLANT ISSUES, FSE PROACTIVELY REPLACED ALL MAJOR COMPONENTS IN THE WATER SYSTEM. REPLACING ALL THE MAJOR COMPONENTS AT ONE TIME SHOULD PREVENT ANY FURTHER PREMATURE FAILURES DUE TO WATER INTRUSION/CORROSION DAMAGE.

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    CORRECT PMA/510K IS K010900.

    Description of Event or Problem · 1

    WATER CONTROLLER BOARD WENT DOWN AND WAS INTERMITTENT. IN THE MIDDLE OF TREATMENT ALL WATER DRAINED FROM THE SYSTEM. CASE CANCELLED. THREE HUNDRED TWENTY SIX SHOCKS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415827 MEDSTONE LITHOTRIPTOR LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL LNS HEALTHTRONICS, INC. MEDSTONE STS-TC LITHOTRIPTER

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR