BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULARIS VARIOSTAR

    MDR report key: 8524356 · Received April 17, 2019

    Report

    Report Number
    3004977335-2018-49409
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    September 20, 2018
    Report Date
    September 20, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    LNS
    PMA / PMN Number
    K070799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DESCRIBED ISSUE WAS INVESTIGATED IN DETAIL. THE TWO RETURNED COMPONENTS "USER INTERFACE VARIOSTAR QNX" (MATERIAL NUMBER 10305399) AND "CABLE" (MATERIAL NUMBER 05531160) WERE TESTED AND EXAMINED IN THE LABORATORY. HOWEVER, NO MALFUNCTION OF THE COMPONENTS WAS IDENTIFIED DURING A TWO-WEEK ENDURANCE TEST AND THE ISSUE COULD NOT BE REPRODUCED. ANOTHER OCCURRENCE OF TABLE MOVEMENT WITHOUT OPERATOR CONTROL WAS COMMUNICATED FROM THIS CUSTOMER SITE AFTER THE REPLACEMENT OF THE ABOVE-MENTIONED COMPONENTS. AS A RESULT, THE URO TABLE WAS REPLACED AND RETURNED FOR INVESTIGATION. AN ENDURANCE TEST OF THE TABLE, SIMULATING THERAPY WITH CONTINUOUSLY TRIGGERED SHOCK WAVES, WAS PERFORMED. EVEN AFTER ONE MONTH OF CONTINUOUS SYSTEM OPERATION, THE FAILURE SCENARIO COULD NOT BE REPRODUCED. NO OTHER OCCURRENCES HAVE BEEN REPORTED FROM THE THIS FACILITY SINCE REPLACING THE URO TABLE. DESPITE THOROUGH INVESTIGATION THE ROOT CAUSE COULD NOT BE DETERMINED, AND THE ISSUE COULD NOT BE REPRODUCED. HOWEVER, NO SIMILAR CASES ARE KNOWN FROM THE INSTALLED BASE. AN INDIVIDUAL ERROR AT THIS SPECIFIC CUSTOMER SYSTEM IS ASSUMED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. NO RISK OF COLLISION IS ATTRIBUTED TO THIS EVENT; HOWEVER, UNINTENDED MOVEMENT MAY CAUSE SHOCK WAVES TO BE APPLIED TO OTHER TISSUES OTHER THAN TARGETED. ADDITIONAL INFORMATION AND MATERIALS WERE REQUESTED FROM THE FACILITY FOR FURTHER ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF UNINTENDED SYSTEM MOVEMENT OF THE MODULARIS VARIOSTAR. DURING A CLINICAL CASE THE PATIENT TABLE MOVED DOWNWARD WITHOUT GIVEN COMMAND FROM THE OPERATOR. THE OPERATOR HAD TO PRESS THE EMERGENCY STOP BUTTON TO STOP THE MOVEMENT. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317482 MODULARIS VARIOSTAR EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER LNS SIEMENS HEALTHCARE GMBH 1157200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other