BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 3702234 · Received February 18, 2014

    Report

    Report Number
    2523209-2014-00004
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    CUSTOM ULTRASONICS INC
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED PT INJURIES AT THIS TIME. CUSTOMER CALLED CUSTOM ULTRASONICS INC. TO PERFORM PREVENTIVE MAINTENANCE ON THE SYSTEM 83 PLUS 2 DEVICE. THE TECHNICIAN NOTICED THAT THE ULTRASONICS WERE NOT WORKING PROPERLY. THE TECHNICIAN WAS NOT ABLE TO TROUBLESHOOT THE PROBLEM AT THE FACILITY. ARRANGEMENTS WERE MADE TO HAVE THE PART SENT BACK TO CUSTOM ULTRASONICS FOR EVAL. THE UNIT IS INOPERABLE AT THIS TIME. THERE IS NO FURTHER INFO AVAILABLE AT THIS TIME. UPON INVESTIGATION OF THE PART, CUSTOM ULTRASONICS INC. WILL SEND A FOLLOW UP REPORT WITH THE ADDITIONAL INFO.

    Description of Event or Problem · 1

    ULTRASONIC SOUND WAVES NOT ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102027 SYSTEM 83 PLUS 9 ENDOSCOPE WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1