BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 3202153 · Received June 28, 2013

    Report

    Report Number
    2523209-2013-00011
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED INJURIES AT THE TIME OF THIS REPORT. CUSTOM ULTRASONICS INC. IS REPORTING THIS INCIDENT WITH AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    REPORTED EVENT: UNIT STOPPED IN MID CYCLE. OUR INVESTIGATION DETERMINED THAT THE FLOW OF VARIOUS BULKHEADS WERE PARTIALLY OCCLUDED DUE TO THE ACCUMULATION OF LINT. ALSO NOTED THAT THE FACILITY WAS NOT USING THE RECOMMENDED DISC FILTERS. THIS CAUSED BACK PRESSURE THAT RESULTED IN THE SYSTEM STOPPING IN MID CYCLE. THE FACILITY REPRESENTATIVE WAS NOT SURE IF THERE WERE ANY SCOPES IN THE PROCESSING CHAMBER AT THIS TIME. HOWEVER, IF THERE WERE SCOPES IN THE PROCESSING CHAMBER WHEN THE UNIT STOPPED THE REPRESENTATIVE STATED THEY WOULD HAVE BEEN REMOVED AND REPROCESSED. CUSTOM ULTRASONICS INC. DID RE-TRAIN THE STAFF ON HOW TO CHECK THE FLOW, USING THE DIAGNOSTIC PART OF THE SERVICE PROGRAM. THE STAFF WAS ALSO TRAINED ON THE IMPORTANCE OF USING THE CORRECT DISC FILTERS, AS RECOMMENDED IN THE SYSTEM 83 PLUS OPERATOR'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297122 SYSTEM 83 PLUS 9 ENDOSCOPE WASHER-DISINFECTOR FLG CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1