BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTHERA SYSTEM

    MDR report key: 16025842 · Received December 21, 2022

    Report

    Report Number
    3006560326-2022-00011
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 7, 2022
    Report Date
    January 31, 2023
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    UDI-DI
    00840763100179
    PMA / PMN Number
    K180623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTHERA CONTROL UNIT AND ASSOCIATED POWER CORD WERE RETURNED TO MERZ ON 19-DEC-2021. THIS CONTROL UNIT HAS BEEN SUBMITTED FOR COMPLETE DIAGNOSTIC EVALUATION AND TESTING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WHEN THE SERVICE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE ULTHERA CONTROL UNIT, HANDPIECE, AND ASSOCIATED POWER CORD WERE RETURNED TO MERZ ON 19-DEC-2022. A PRELIMINARY INVESTIGATION WAS PERFORMED BY A MERZ BIOMEDICAL ELECTRICAL ENGINEER. DURING THIS EVALUATION, NO SIGNS OF DAMAGE, ELECTRICAL DAMAGE, OR OTHER DEVIATIONS WERE OBSERVED WITH THE CONTROL UNIT, HANDPIECE, OR THE POWER CORD. ALL THREE DEVICES WERE EVALUATED AND FOUND TO BE IN NORMAL WORKING CONDITION. THE CONTROL UNIT, HANDPIECE, AND POWER CORD WERE THEN SUBMITTED FOR COMPLETE DIAGNOSTIC EVALUATION AND TESTING. DURING EVALUATION, NO BLANK SCREEN ISSUES WERE OBSERVED AND NO SPARKING, EVIDENCE OF SPARKING, OR OTHER RELATED ISSUES WERE DUPLICATED OR IDENTIFIED. THE POWER DISTRIBUTION BOARD TEST FAILED, AND THIS COMPONENT WAS REPLACED TO RESOLVE THE ISSUE. THE UNIT WAS POWERED ON/OFF SEVERAL TIMES AND TESTED BY FIRING 200 LINES WITH MULTIPLE TRANSDUCERS. NO OTHER ISSUES WERE FOUND, AND THE DEVICE MET ALL FUNCTIONAL REQUIREMENTS. BASED ON THESE FINDINGS, THE REPORTED ISSUES OF SPARKING OCCURRING AT THE CONNECTION OF THE ULTHERA CONTROL UNIT AND POWER CORD AND BLANK SCREEN WERE NOT CONFIRMED. DURING SYSTEM MANUFACTURING AND SERVICE AND REPAIR ACTIVITIES, THE POWER DISTRIBUTION BOARD ASSEMBLY AND ASSOCIATED CABLES/COMPONENTS ARE TESTED TO ENSURE ALL CONNECTIONS AND THE POWER SUPPLIED TO THE INTERNAL COMPONENTS IS CORRECT AND WITHIN SPECIFIED LIMITS. A DEFECTIVE POWER DISTRIBUTION BOARD COULD NOT CAUSE SPARKS FROM WHERE THE POWER CORD CONNECTS TO THE BACK OF THE CONTROL UNIT. ADDITIONAL SAFETY MECHANISMS ARE BUILT INTO THE SYSTEM TO ADDRESS THIS POTENTIAL PROBLEM. FOR EXAMPLE, A FUSE WOULD BLOW/CUT OUT IN THE POWER ENTRY ASSEMBLY OR POWER DISTRIBUTION BOARD THAT WILL EVENTUALLY RENDER THE SYSTEM UNUSABLE. THE ALLEGED SPARKS WHERE THE POWER CORD CONNECTS TO THE BACK OF THE CONTROL UNIT COULD POTENTIALLY BE CAUSED BY A POWER CORD THAT IS NOT PROPERLY INSERTED INTO THE POWER ENTRY ASSEMBLY MAKING INTERMITTENT CONTACT; HOWEVER, THIS ISSUE WAS NOT REPLICATED DURING EVALUATION. AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS, REWORK, OR NON-CONFORMANCES WERE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE. ALL TESTS CONDUCTED PASSED ON THE FIRST ATTEMPT. AN EVALUATION OF THE SERVICE HISTORY RECORD (SHR) FOR THIS CONTROL UNIT REVEALED THIS DEVICE HAS NOT BEEN RETURNED FOR SERVICE OR REPAIR SINCE DISTRIBUTION. A REVIEW OF THE MOST RECENT ULTHERA PRODUCT COMPLAINT TRENDING ANALYSIS FOR TOUCHSCREEN/DISPLAY ISSUE AND SMOKE/SPARK REVEALED NEITHER ISSUE HAS OCCURRED AT A HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. ALTHOUGH THE SPARKING ISSUE WAS NOT REPLICATED DURING EVALUATION AND THIS CONTROL UNIT COMPLETED SERVICING AND REPAIR, IN AN ABUNDANCE OF CAUTION THIS DEVICE WILL BE SCRAPPED TO ENSURE NO SAFETY RISK. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED VIA PHONE CALL AN ULTHERA CONTROL UNIT THAT WAS GIVING A BLANK SCREEN. UPON TURNING OFF THIS DEVICE AND POWERING BACK ON, SPARKS WERE OBSERVED EMITTING FROM THE CONNECTION WHERE THE POWER CORD CONNECTS TO THE BACK OF THE CONTROL UNIT. TROUBLESHOOTING WAS PERFORMED BY REQUESTING THE USER TO UNPLUG THE DEVICE AND ENSURE THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. UPON CONFIRMATION OF THE POWER CORD BEING FULLY SEATED, THE DEVICE WAS AGAIN PLUGGED INTO AN OUTLET. WHEN THE UNIT WAS PLUGGED IN, SPARKS WERE REPORTEDLY EMITTING FROM THE SAME LOCATION ON THE BACK OF THE CONTROL UNIT. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406836 ULTHERA SYSTEM ULTHERA SYSTEM OHV MERZ NORTH AMERICA, INC. UC-1 00840763100179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other