BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTHERA SYSTEM

    MDR report key: 11787534 · Received May 6, 2021

    Report

    Report Number
    3013840437-2021-00120
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    UDI-DI
    00840763100179
    PMA / PMN Number
    K180623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTHERA CONTROL UNIT AND ASSOCIATED POWER CORD WERE RETURNED TO MERZ ON 23-APR-2021. A PRELIMINARY INVESTIGATION WAS PERFORMED BY A MERZ SENIOR BIOMEDICAL ENGINEER ON 29-APR-2021. DURING THIS INVESTIGATION, NO DAMAGE, EVIDENCE OF CHARRING, OR OTHER DEVIATIONS WERE OBSERVED WITH THE CONTROL UNIT NOR THE POWER CORD. THE UNIT WAS EVALUATED AND WAS FOUND TO BE IN NORMAL WORKING CONDITION. IN AN ATTEMPT TO REPLICATE THE ISSUE, THE POWER CORD WAS PARTIALLY INSERTED INTO THE CONTROL UNIT AND MINOR SPARKING WAS OBSERVED. THIS CONDITION MAY BE OBSERVED ON MOST AC POWERED DEVICES WHEN THERE IS A POOR CONNECTION BETWEEN A POWER SUPPLY AND THE DEVICE. THIS CONTROL UNIT HAS BEEN SENT 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.

    Description of Event or Problem · 1

    DURING A PHONE CALL WITH A PRACTICE FOR AN UNRELATED EVENT ON (B)(6) 2021, MERZ ULTHERA RECEIVED INFORMATION AN ULTHERA CONTROL UNIT WAS EMITTING SPARKS FROM THE BACK OF THE UNIT WHERE THE POWER CORD PLUGS INTO THE BACK OF THE UNIT. THIS ISSUE OCCURRED WHEN THE USER MOVED THIS DEVICE TO ANOTHER LOCATION WITHIN THE PRACTICE AND PLUGGED IT INTO THE WALL OUTLET. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680192 ULTHERA SYSTEM ULTHERA SYSTEM OHV MERZ NORTH AMERICA, INC. UC-1 00840763100179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other