BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 3894625 · Received February 19, 2014

    Report

    Report Number
    2523209-2014-00011
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED ENGINEER STATED THAT THE WHITE SUBSTANCE WAS SENT TO A LAB FOR EVAL. DURING A PRELIMINARY EVAL, IT WAS CONFIRMED THAT THE SUBSTANCE WAS NOT A BACTERIA OR FUNGUS. THE FACILITY IS WAITING A FINAL REPORT, THEY WILL CONTACT CUSTOM ULTRASONICS INC. WHEN THE REPORT IS AVAILABLE. THERE WERE NO REPORTED FAILURES WITH THE SYSTEM 83 PLUS. THE CUSTOM ULTRASONICS'S SERVICE TECHNICIAN DID PROPERLY CLEAN THE UNIT. THE UNIT IS CURRENTLY WORKING AS INTENDED. THE BIOMED ENGINEER STATED THAT THE USER WAS BACK TO WORK AND PROCESSING SCOPES SINCE THE ROOM HAS BEEN RECENTLY RE-OPENED. NO FURTHER INFO AVAILABLE AT THIS TIME, AS INFO BECOMES AVAILABLE IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    BUILD UP OF WHITE SUBSTANCE IN, ON AND AROUND THE SYSTEM 83 PLUS UNITS THE SAME SUBSTANCE WAS FOUND ON WALLS AND AIR EXCHANGES IN THE SAME DEPARTMENT. THIS WHITE SUBSTANCE DID APPEAR IN ANOTHER AREA OF THE UNIT. THE DOCTORS CLOSED THE UNIT AFTER A USER IN THE DEPARTMENT CHECKED INTO THE ER REPORTING RESPIRATORY AND IRRITATION AS A RESULT OR WORKING IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106011 SYSTEM 83 PLUS ENDOSCOPE WASHER - DISINFECTOR KOG CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1