BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 3597517 · Received November 27, 2013

    Report

    Report Number
    2523209-2013-00016
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 6, 2013
    Manufacturer
    CUSTOM ULTRASONIC INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED INJURIES AT THE TIME OF THIS REPORT. DURING PREVENTIVE MAINTENANCE A SERVICE TECHNICIAN NOTICED THE ULTRASONIC SOUND WAVES WERE NOT ENGAGED. THE TECHNICIAN REPLACED THE GENERATOR BOARD, HOWEVER THE GENERATOR BOARD WAS NOT SENT BACK TO THE MANUFACTURER FOR EVALUATION. THE TECHNICIAN STATED THAT THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(4) 2013 AT THAT TIME THE ULTRASONIC SOUND WAVES WERE REPORTED TO BE WORKING. CUSTOM ULTRASONICS INC. MADE SEVERAL ATTEMPTS TO FOLLOW UP WITH THE FACILITY. IF INFORMATION BECOMES AVAILABLE CUSTOM ULTRASONICS INC. WILL SUBMIT A FOLLOW UP REPORT. THERE MAY BE A LOW RISK OF INFECTION ASSOCIATED WITH THIS ISSUES AS STATED IN THE RISK ASSESSMENT SUPPLIED TO THE CUSTOMER. CUSTOM ULTRASONICS INC. IS REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ULTRASONIC SOUND WAVES NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621059 SYSTEM 83 PLUS 9 WASHER-DISINFECTOR FEB CUSTOM ULTRASONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1